Lilly profit hit by weak demand for pandemic drugs

 

Drugmaker Eli Lilly and Co fell short of quarterly profit expectations on Tuesday, as persistent regulatory actions in the United States and lower demand hurt sales of its COVID-19 therapies.

The distribution of its antibody cocktail was paused by the U.S. health officials in late June after lab analyses showed it was not effective against variants first identified in Brazil and South Africa.

Hospitals have also struggled with administering the drugs bamlanivimab and etesevimab, slowing its sales, which have further been dented by vaccine rollouts in the United States.

The U.S. health regulator have also denied the lone use of bamlanivimab to treat COVID-19 in response to variants that could be resistant to the treatment.

Shares of the company fell 2% before the bell after it lowered the upper end of its annual sales forecast for the therapies to $1.1 billion, from its prior view of between $1 billion and $1.5 billion.

Sales of its antibody treatments came in at $148.9 million in the quarter compared to $810.1 million in the previous quarter.

However, sales of its blockbuster diabetes drug Trulicity rose 25% to $1.54 billion, roughly in line with estimates of $1.53 billion.

Other growth drivers such as psoriasis drug Taltz also exceeded market expectations, but sales of some diabetes treatments missed the Wall Street targets.

Sales of insulin injection Humalog rose 9% to $607.6 million, but missed estimates of $622.14 million.

Net income fell to $1.39 billion in the quarter ended June 30 from $1.41 billion a year ago.

Excluding items, Lilly earned $1.87 per share, missing estimates of $1.89 per share, according to Refinitiv IBES data

The drugmaker said it plans to submit a marketing application for its experimental Alzheimer's drug, donanemab, by the end of this year.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Drugmaker-Eli-Lilly-profit-hit-by-weak-demand-for-pandemic-drugs-36049416/

Bausch Health plans IPO for medical aesthetics business to cut debt

 

Bausch Health Cos Inc said on Tuesday it planned to pursue an initial public offering of its medical aesthetics business Solta Medical, as the company looks to further cut debt and hasten the spin-off of eye care unit Bausch + Lomb.

The Canadian drugmaker, previously known as Valeant Pharmaceuticals, has been shedding non-core assets to pay down debt, which piled up due to aggressive deal-making under former Chief Executive Officer Mike Pearson.

Bausch said in March it would sell its entire stake in Egypt's Amoun Pharmaceutical Co SAE and last year announced plans to spin off Bausch + Lomb.

Solta's IPO will now create three companies including Bausch + Lomb and Bausch's drug products business Bausch Pharma.

Solta, which reported 2020 revenue of $253 million, offers anti-aging laser skin treatments such as Clear + Brilliant and is part of Bausch's ortho dermatologics business.

The company's current chief strategy officer and president of its ortho dermatologics unit Scott Hirsch has been named as the chief executive officer of Solta, Bausch said.

The IPO, expected in the fourth quarter of 2021 or the first half of 2022, will unlock the value of Solta and give Bausch ownership of an entity that will compare more favorably to other medical aesthetic companies, the drugmaker said.

As a publicly traded company, Solta will be domiciled in Canada and there are plans for it to be listed on the Nasdaq stock exchange, Bausch said.

Davis, Polk & Wardwell in the United States and Osler, Hoskin & Harcourt in Canada are acting as lead legal counsels for the IPO.

As of June 30, Bausch Health had total long-term debt of $23.69 billion, down from $24.19 billion in December.

https://www.marketscreener.com/news/latest/Bausch-Health-plans-IPO-for-medical-aesthetics-business-to-cut-debt--36050232/

Army gives Pfizer $3.5B contract to make 500 million COVID vaccine doses

 The Pentagon announced Monday the US Army had awarded Pfizer a $3.5 billion contract to manufacture 500 million doses of its COVID-19 vaccine by the end of next year for distribution around the world.

The order matches the number of Pfizer-BioNTech vaccine doses purchased by the US government under an agreement announced last year by the Trump administration. Last month, Pfizer announced that the latest batch of 200 million doses would be delivered between October of this year and April of 2022.

In June, Pfizer and Germany-based BioNTech announced that they would provide 500 million doses “at a not-for-profit price” to the feds for distribution to more than 100 countries around the world, most of them in Africa.

“Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible,” Pfizer Chairman and CEO Albert Bourla said at the time. “COVID-19 has impacted everyone, everywhere, and to win the battle against this pandemic, we must ensure expedited access to vaccines for all.”

The Pentagon announced that Pfizer has been given a $3.5 billion contract to produce 500 million doses of COVID-19 vaccine.

REUTERS/Jason Reed (UNITED STATES)/File Photo

The two-shot Pfizer-BioNTech vaccine is one of three approved on an emergency basis by the Food and Drug Administration (FDA). With the number of COVID-19 cases surging due to the highly contagious Delta variant and the vaccination rate slowing to a crawl, the FDA announced last week it was reshuffling resources in an effort to grant full approval to the Pfizer and Moderna vaccines as quickly as possible.

“This will remove one more layer for the vaccine-hesitant,” FDA official Peter Marks told The Washington Post. “If all this does is get five to 10 million more people vaccinations down south, that will save lives.”

Last month, a study funded by Public Health England and published in the New England Journal of Medicine found that two doses of the Pfizer-BioNTech vaccine were 88 percent effective at preventing severe illness from the Delta variant of COVID-19 and 93.7 percent effective at preventing severe illness from the original strain of the virus.

https://nypost.com/2021/08/02/army-gives-pfizer-3-5b-to-make-500m-covid-vaccine-doses/

Genentech: FDA Grants Priority Review For Tecentriq

 Genentech, a member of the Roche Group (RHHBY.PK), said FDA has granted priority review for Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. The company's application is based on disease-free survival results from an interim analysis of the phase III IMpower010 study. Results from the trial were presented at the ASCO Annual Meeting.

The FDA is reviewing the application under the Real-Time Oncology Review pilot program, and is anticipated to make a decision on approval by December 1, 2021.

https://www.nasdaq.com/articles/genentech%3A-fda-grants-priority-review-for-tecentriq-quick-facts-2021-08-03

Novartis : FDA Lifts Partial Clinical Trial Hold On Spinal Muscular Atrophy Study

 Novartis (NVS) said the U.S. Food and Drug Administration has concluded that OAV-101 intrathecal or IT clinical trials for spinal muscular atrophy or SMA patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019.

The FDA's decision was based on data from Novartis' comprehensive nonclinical toxicology study in non-human primates that addressed all issues identified, including questions of dorsal root ganglia injury following intrathecal administration.

Novartis said it now plans to initiate STEER, a global pivotal Phase 3 registration-enabling study to evaluate the clinical efficacy, safety, and tolerability of OAV-101 IT in treatment naïve patients who are between two and 18 years of age, able to sit, but have never walked. While disease progression is slower in patients with later-onset SMA, there are significant unmet needs.

https://www.nasdaq.com/articles/novartis-%3A-fda-lifts-partial-clinical-trial-hold-on-spinal-muscular-atrophy-study-2021-08

Eli Lilly Earnings Fall Short, Sales Top; LLY Stock Falls Slightly

Early Tuesday, Eli Lilly (LLY) reported adjusted earnings of $1.87 per share on $6.74 billion in second-quarter sales. In response, LLY stock fell slightly.

On average, analysts polled by FactSet expected Lilly earnings of $1.89 per share and $6.6 billion in sales.

In the year-earlier period, Lilly earned $1.89 per share on $5.5 billion in sales.

For the year, the pharmaceutical company still sees EPS of $7.80-$8.00. It expects revenue of $26.8 billion to $27.4 billion.  Analysts projected Lilly earnings of $7.89 per share on $27.21 billion in sales.

In premarket trading on the stock market today, LLY stock fell 1.5%. Eli Lilly has been trading near record highs.

https://www.investors.com/news/technology/lly-stock-eli-lilly-earnings-q2-2021/

Volume 0%

 

Outlook Therapeutics: Positive Efficacy, Safety Data in Pivotal Phase 3 Wet AMD Trial

 

• In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41% of subjects gaining at least 15 letters
  
  

• In NORSE TWO, ONS-5010 was safe and well tolerated
  
  

• Management to host conference call and webcast today at 8:00 a.m. ET
  

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced positive clinical and highly statistically significant top-line results from its pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab) for treatment of neovascular age-related macular degeneration (wet AMD). Outlook Therapeutics will host a conference call and webcast today, August 3, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.

Conference Call and Webcast Details

Outlook Therapeutics management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Tuesday, August 3, 2021, at 8:00 a.m. ET. Interested participants may access the conference call by dialing (877) 407-9708 (domestic) or (201) 689-8259 (international). The live webcast will be accessible on the Events page of the Investors section of the Outlook Therapeutics website, outlooktherapeutics.com, and will be archived for 90 days.

https://finance.yahoo.com/news/outlook-therapeutics-reports-positive-efficacy-100000853.html