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Wednesday, April 28, 2021

Boston Scientific Raises 2021 Guidance

 Boston Scientific Corp. raised its outlook for 2021 and made projections for the second quarter as it reported higher first-quarter profit and sales.

The Marlborough, Mass.-based medical-products company on Wednesday said it sees full-year net sales growth of about 16% to 19%, or about 15% to 18% on an organic basis. In February, it guided for a sales growth of 13% to 19%, or 12% to 18% on an organic basis.

The company said it expects full-year earnings of 81 cents a share to 88 cents a share, or $1.53 a share to $1.60 a share on an adjusted basis. It previously guided for earnings of 72 cents a share to 82 cents a share, or $1.50 a share to $1.60 a share on an adjusted basis.

For the second quarter, Boston Scientific said it sees net sales growing about 46% to 50%, or about 44% to 48% on an organic basis. It expects earnings of 16 cents a share to 18 cents a share, or 36 cents a share to 38 cents a share on an adjusted basis.

Organic sales exclude the effect of foreign-currency fluctuations and the acquisition of Preventice Solutions Inc., with no prior period related net sales, as well as the intrauterine health franchise, which the company divested in the second quarter of 2020, and the specialty pharmaceuticals business, which the company divested in the first quarter of 2021.

https://www.marketscreener.com/quote/stock/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-Raises-2021-Guidance-33092520/

Glaxo pursuing split as easing of COVID curbs aids earnings

 

Plans for GlaxoSmithKline to split in two are "well underway" it said on Wednesday after exceeding first-quarter earnings forecasts as an easing of COVID-19 curbs meant more clinic visits for critical treatments such as HIV and routine shots.

GSK has fallen behind in the coronavirus vaccines race and its broader strategy has been under the microscope after a report that U.S. activist investor Elliott built up a significant stake.

The British drugmaker said it would provide details on June 23 on its plan to separate next year into an over-the-counter products business and another for prescription medicines and vaccines.

Chief Executive Emma Walmsley said she was focused on GSK's broader transformation and delivering shareholder value.

The separation was spearheaded by Walmsley, a former head of GSK's consumer business, to simplify operations.

Walmsley took the top job in 2017 despite some investor pressure to name an outsider as CEO and such calls may grow with Elliott's arrival on the register.

"With major structural change on the cards at GSK, with or without Elliott's alternative vision, it looks set to be a year of forced evolution at GSK," Steve Clayton, manager of Hargreaves Lansdown's Select UK Income Shares fund, said in a note.

GSK said that turnover for the three months to March fell 15% to 7.42 billion pounds ($10.28 billion) at constant currency rates, while adjusted earnings stood at 22.9 pence per share, down by a third.

Analysts had expected adjusted earnings of 21.9 pence per share and sales of 7.83 billion pounds, a company-compiled consensus https://www.gsk.com/en-gb/investors/analyst-consensus/analyst-consensus of 17 analysts showed.

Walmsley launched GSK's split, which involves merging its over-the-counter products business into a venture with Pfizer and separating this from its prescription medicines and vaccines units, last year.

Investments to prepare for the division have hurt earnings, but GSK hopes the streamlined operations resulting from it will pay off in the long term.

Walmsley said that while GSK's consumer health business had great prospects and a "fantastic" leadership team, she would seek to remain in control of the bigger picture.

"I'm very focused on leading GSK through that successful separation and beyond," Walmsley told a results briefing, adding that she saw her role as CEO as setting the strategy, hiring top people and allocating capital, while leaving the medical science to the experts.

"I've clearly laid out from day one ... and included in that has been the best possible R&D leadership in the world," Walmsley said in response to suggestions that her lack of scientific background meant she would be better suited to lead the consumer business once GSK completes its planned split.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-nbsp-GSK-pursuing-split-as-easing-of-COVID-curbs-aids-earnings-33092467/

BioNTech CEO sees China approval for COVID shot by June

  BioNTech expects that the COVID-19 vaccine it is making with Pfizer will win approval from the Chinese health authorities “by June at the latest”, Chief Executive Ugur Sahin said on Wednesday.

This would mean that it would be possible to distribute the vaccine in China from July, the founder of the biotech startup told an online briefing with the German foreign correspondents’ association.

“I am optimistic that we can help the people of China,” said Sahin, adding that local partner Shanghai Fosun Pharmaceutical Group Co Ltd was “a great company”. 

https://www.reuters.com/article/health-coronavirus-vaccine-biontech-chin/biontech-ceo-sees-china-approval-for-covid-shot-by-june-idUSL8N2ML3JQ

Protalix Stock Falls After FDA Slaps CRL For PRX-102 Application In Fabry Disease

 

  • Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, have received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‑102) for Fabry disease.

  • "While disappointing, we remain confident in the strength of our data and in the depth of our program," said Dror Bashan, Protalix's President, and CEO.

  • The application submission for PRX-102 included a comprehensive set of preclinical, clinical, and manufacturing data compiled from the completed Phase 1/2 clinical trial of PRX-102.

  • PRX‑102 is currently in Phase 3 trial BALANCE study sponsored by Protalix and various long-term extension studies.

  • In addition, Chiesi provides access to pegunigalsidase alfa through its Expanded Access Program for Fabry disease patients in the U.S.

  • As initially planned, Chiesi will continue to coordinate with the European Medicines Agency (EMA) to file for regulatory approval of PRX‑102 in the European Union this year.

Teva misses on revenue, reaffirms guidance in Q1

 

  • Revenues of $4.0 billion

  • GAAP diluted EPS of $0.07

  • Non-GAAP diluted EPS of $0.63

  • Cash flow used in operating activities of $405 million

  • Free cash flow of $59 million

  • Full year 2021 business outlook reaffirmed:

    • Net revenues of $16.4-16.8 billion

    • EBITDA of $4.8 - $5.1 billion

    • EPS of $2.50 - $2.70

    • Free cash flow of $2.0 - $2.3 billion

  • https://finance.yahoo.com/news/teva-reports-first-quarter-2021-110000380.html

Flexion: Positive prelim data on knee osteoarthritis

 

  • Findings from a Phase 1 single ascending dose trial indicate the low dose of FX201, an intra-articular gene therapy candidate for osteoarthritis (OA), was generally well-tolerated

  • Two of five patients (40%) treated with FX201 in the low-dose, single ascending dose cohort reported substantial improvement in pain out to Week 24

  • No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient

  • Longer term follow-up data from the low-dose cohort will be presented at ASGCT on May 11

Sanofi: Strong increase in Q1 2021 business, guidance reaffirmed

 Sanofi Chief Executive Officer, Paul Hudson, commented:

“Our strong first-quarter performance is the result of the continued execution of our Play to Win strategy to drive growth and bring innovative medicines to patients. Dupixent® continues its outstanding performance with impressive growth in the U.S. and strong uptake in global markets, including China. Vaccines delivered growth in its core segments. We initiated and completed enrollment of our Phase 2 study for our recombinant COVID-19 vaccine candidate in the first quarter and results are expected next month. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO. Sanofi is uniquely positioned to make this difference to society, which can be scaled and sustained over time, given our portfolio of essential medicines and broad geographic presence.”

https://finance.yahoo.com/news/sanofi-continued-growth-trajectory-strong-053000973.html