| To: Moonray who wrote (623) | 12/17/2021 11:51:41 AM | | From: Lance Bredvold | | | | I have a 270 call sold for January and during the pop this week sold another at $280 for July. While the news has been good and I have actually penciled in EPS of $8.20 (above the $7.95 speculated 2 posts ago) that puts my $270 call at a PE of nearly 33. That's more than the company has shown as a high for any of the last 10 years except 2021. Clearly $280 is just as pricy so I'm feeling pretty secure in my sales which were both for $22.00. Of course I could be wrong, but I think the odds are excellent that I'll profit from these sales.
If I had some of my shares in retirement accounts I'd probably sell as it bounced so high the other day, but I don't want to claim the huge gain on the shares in my taxable accounts at this time, so a nice 8% bonus is welcome though it also entails some tax expense. |
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| To: Lance Bredvold who wrote (624) | 4/8/2022 9:15:38 PM | | From: Lance Bredvold | | | | | I don't know about anyone else, but I just don't believe prices and PE's just keep going up forever. The Jan 270 expired nicely but the July 280 is far underwater and an additional Oct 300 is also looking pretty dumb at the moment. Yet getting over $20 for each one feels pretty good for a while at least and I think I'll have the courage to sell a $320 whenever I can get $25 or so for them. |
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| To: Lance Bredvold who wrote (625) | 4/9/2022 1:45:09 PM | | From: JamesK | | | | Really nice move in LLY. Moves aren't as strong but similar chart patterns in AZN MRK and big bios like AMGN VRTX REGN.
Maybe with the FED slamming on the brakes there is rotation into less economically sensitive areas.
Might feel bad losing some of your stock but be happy you're getting good prices. Sometimes I buy back the options and sell new ones in your situation. |
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| From: Glenn Petersen | 6/28/2023 10:48:08 AM | | | | | | As drugmakers race to develop the next big weight loss pill, Eli Lilly may have an edge
PUBLISHED WED, JUN 28 20239:35 AM EDT
UPDATED 28 MIN AGO
Annika Kim Constantino @ANNIKAKIMC
CNBC.com
KEY POINTS
-- Drugmakers are jockeying to capitalize on the next major innovation coming to the blockbuster weight loss industry.
-- For now, one experimental oral drug from Eli Lilly appears to have an edge over pills from Novo Nordisk and Pfizer – even though it may not win U.S. approval first.
--,Eli Lilly’s orforglipron appears to be the top contender due to its strong efficacy data and convenience as a once-daily pill without dietary restrictions.
-- But pivotal data from several pharmaceutical companies is slated to come out later this year and pricing of all the major drugs is still uncertain.
Drugmakers are jockeying to capitalize on the next major innovation coming to the blockbuster weight loss industry: effective, convenient and potentially affordable obesity pills.
An estimated 40% of U.S. adults are obese, making a successful pill a massive opportunity.
It’s too early to crown a winner, especially since pivotal data from several pharmaceutical companies is slated to come out later this year. And there’s still the all-important question of pricing to come down for the major players.
But for now, one experimental oral drug from Eli Lilly appears to have an edge over pills from Novo Nordisk and Pfizer – even though it may not win U.S. approval first.
All three manufacturers are developing oral versions of GLP-1s, a class of drug that mimics a hormone produced in the gut to suppress a person’s appetite. Novo Nordisk’s popular Wegovy and Ozempic treatments, which sparked a weight loss industry gold rush last year, are weekly GLP-1 injections also known as semaglutide.
The pills are easier to manufacture than injections, which come in the form of single-use pens. That means the oral drugs could potentially help alleviate the supply shortages plaguing their injectable counterparts.
Pills are also typically cheaper than injections, though it’s unclear if that will be the case with the obesity pills.
Wegovy’s list price tops $1,300 per monthly package, and Ozempic’s is about $935. Novo Nordisk has a low-dose oral version of semaglutide that has the same list price as Ozempic for a monthly package of 30 tablets. That pill, marketed as Rybelsus, is only approved for Type 2 diabetes.
None of the three drugmakers have provided estimates for how much the new obesity pills would cost.
Novo Nordisk has one important advantage: The Danish company has already released phase three clinical trial results for its high-dose version of oral semaglutide, which is intended for weight management, and told CNBC it expects to file for Food and Drug Administration approval later this year.
Eli Lilly is still in the middle of phase three clinical trials on its oral drug, orforglipron, meaning it’s likely to hit the market later.
Still, analysts are confident in the competitive edge of orforglipron in the long run, especially after Eli Lilly unveiled phase two clinical trial results last week that showcased the drug’s strong efficacy profile.
Strong efficacy profile
According to Eli Lilly’s phase two results, overweight or obese patients who took 45 milligrams of orforglipron once a day lost up to 14.7% of their body weight after 36 weeks. That compares with 2.3% weight loss for people who received a placebo.
Eli Lilly’s results appear consistent with the weight reduction caused by Novo Nordisk’s pill, but were achieved over a shorter trial period.
Overweight or obese patients who took 50 milligrams of Novo Nordisk’s drug once a day saw an average weight loss of 15.1% after 68 weeks, according to phase three clinical trial results released Sunday.
Bank of America analyst Geoff Meacham said in a Sunday research note that Eli Lilly’s available orforglipron data “compares quite favorably” to Novo Nordisk’s oral semaglutide, “cross trial comparison caveats aside.”
Cantor Fitzgerald analyst Louise Chen told CNBC that orforglipron could potentially achieve an even greater level of weight loss over a longer trial period.
“The more you use these drugs, the more weight loss you’ll see until it plateaus, right?” Chen said. “So the thought is, if you’re getting pretty close to semaglutide’s weight loss in almost roughly half the time with orforglipron, you will probably exceed it.”
Chen said the hope is that orforglipron leads to similar reduction as Eli Lilly’s injection tirzepatide, which resulted in weight loss of around 22% after 72 weeks.
The company’s phase three clinical trials on orforglipron will study the drug over longer time periods.
At least for now, analysts say Eli Lilly’s pill may also have the upper hand over Pfizer’s oral GLP-1, danuglipron, which is still in phase two clinical trials.
Patients with Type 2 diabetes who took a 120-milligram version of danuglipron twice a day lost around 10 pounds on average after 16 weeks, according to results from one phase two clinical trial.
It’s difficult to compare danuglipron’s efficacy to that of other oral GLP-1s due to differing patient populations and the lack of longer-term data on the drug.
A Pfizer spokesperson told CNBC that the company is still studying the drug in further phase two clinical trials and “would also look to have longer data” beyond the 16-week mark in the future.
Ease of use
Wells Fargo analyst Mohit Bansal said in a research note that Pfizer’s danuglipron will be challenged to compete in the oral GLP-1 space given Eli Lilly’s strong orforglipron data.
He added that physicians generally prefer once-daily pills — like orforglipron — over twice-daily drugs like danuglipron.
Health experts seem to agree: “Patient compliance increases a lot if it’s a once-a-day pill, so it’s definitely a big advantage. People often end up missing a few times a week if they have to take something twice a day,” said Dr. John Yoon, an endocrinology professor at UC Davis Health.
Pfizer is developing a once-daily version of danuglipron.
The company on Monday also said it would stop developing another experimental pill, lotiglipron, which Bansal said had been the “more attractive GLP-1” in Pfizer’s portfolio since it’s only taken once a day. Shares of Pfizer fell 5% Monday following that news.
But Pfizer and Eli Lilly do share one key advantage over Novo Nordisk’s oral semaglutide: no dietary restrictions.
Patients need to take Novo Nordisk’s oral semaglutide in the morning on an empty stomach with no more than four ounces of plain water, according to the FDA label for the low-dose, approved version of the drug. They’re instructed to wait 30 minutes before eating, drinking or taking other oral medicines.
That’s because Novo Nordisk’s oral semaglutide is a peptide medication, which is more difficult for the gut to absorb, according to Dr. Eduardo Grunvald, medical director for UC San Diego’s Center for Advanced Weight Management.
“If you take it with food or drink, it just won’t get absorbed efficiently,” Grunvald told CNBC.
He said pills from Eli Lilly and Pfizer are non-peptide GLP-1s, which are absorbed more easily and don’t require dietary restrictions.
Cantor Fitzgerald’s Chen said market research suggests that those restrictions are a “big negative for patients,” making the pills from Eli Lilly and Pfizer convenient alternatives.
Overall, Eli Lilly’s orforglipron appears to be the top contender in the weight loss pill space due to its strong efficacy data and convenience as a once-daily pill without dietary restrictions.
But Chen emphasized that the data unveiled later this year could potentially change that: “Save some room for the new data coming.”
For health experts like Grunvald, naming a winner in the oral weight loss drug space is less important.
“I think these oral GLP-1s mean having more tools in our toolbox, having more options for different people who might react differently to different medicines,” he said. “That’s really the future of this all.”
Eli Lilly weight loss pill may best Pfizer, Novo Nordisk drugs (cnbc.com) |
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| To: Glenn Petersen who wrote (627) | 11/10/2023 7:52:41 AM | | From: Glenn Petersen | | | | FDA approves Eli Lilly’s tirzepatide for weight loss, paving way for wider use of blockbuster drug
PUBLISHED WED, NOV 8 202312:20 PM EST
UPDATED WED, NOV 8 20238:00 PM EST
Annika Kim Constantino @ANNIKAKIMC
CNBC.com
KEY POINTS
- The Food and Drug Administration approved Eli Lilly’s tirzepatide drug for weight loss, paving the way for even wider use of the blockbuster medication.
- The active ingredient in the drug, tirzepatide, has already been approved for the treatment of Type 2 diabetes under the name Mounjaro since May 2022.
- But the FDA’s new approval means adults who have obesity or are overweight with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.
Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
Cristina Arias | Cover | Getty Images
The Food and Drug Administration on Wednesday approved Eli Lilly’s blockbuster drug tirzepatide for weight loss, paving the way for even wider use of the treatment in the U.S.
The active ingredient in the drug, tirzepatide, has already been approved for the treatment of Type 2 diabetes under the name Mounjaro since May 2022.
But the FDA’s new approval means adults who have obesity or are overweight with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.
Zepbound should be available in the U.S. by the end of the year, and will carry a list price of about $1,060 for a month’s supply, according to a release from Eli Lilly.
Before Wednesday’s approval, many patients had used tirzepatide off-label for weight loss, adding to a frenzy of demand for treatments that can help patients shed pounds, such as Novo Nordisk’s Wegovy and Ozempic. All three drugs have faced supply constraints for months due to soaring demand.
The weight lossapproval further establishes Eli Lilly as a formidable competitor to Novo Nordisk in the budding obesity drug market, which Wall Street analysts believe could grow to a $100 billion industry by 2030. The increased use of drugs has raised questions about how the changes will affect an array of industries — though it may be too early to tell how many people will use them.
The approval also comes as obesity affects an estimated 650 million adults globally, and roughly 40% of the adult population in the U.S.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said Dr. John Sharretts, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
How well Zepbound works
Zepbound is an injection administered once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dose sizes of 5, 10 or 15 milligrams per week.
The drug works by activating two naturally produced hormones in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
The combination is said to slow the emptying of the stomach, making people feel full for longer and suppressing appetite by slowing hunger signals in the brain.
The FDA said the approval was based on two of Eli Lilly’s late-stage trials on tirzepatide, which evaluated its effects on weight loss after 72 weeks.
In a late-stage study of more than 2,500 adults with obesity but not diabetes, those taking 5 milligrams of tirzepatide for 72 weeks lost about 16% of their body weight on average. Higher doses of the drug were associated with even more weight loss, with a 15-milligram dose leading to 22.5% weight loss on average.
Another late-stage study found that tirzepatide caused up to 15.7% weight loss among people who are obese or overweight and have Type 2 diabetes.
Pricing, supply constraints
Still, access to tirzepatide and other diabetes and obesity treatments remains a big challenge.
The list price of tirzepatide for weight loss is $1,059.87 per month for six different dose sizes, which is about 20% lower than that of Wegovy, Eli Lilly said in a press release. The company noted that the amount a patient pays out of pocket will likely be less if they have insurance.
Eli Lilly also said it is launching a commercial savings card program to expand access to Zepbound, which could allow people with insurance coverage for the drug to pay as low as $25 for a one-month or three-month prescription. Meanwhile, those whose insurance does not cover Zepbound may be able to pay as low as $550 for those prescriptions.
“Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it,” said Mike Mason, executive vice president and president of Eli Lilly Diabetes and Obesity, in a statement.
The bigger issue is that many insurance companies are dropping weight loss drugs from their plans. Those insurers cite the extreme costs of covering those medications, and some say they want to see more data demonstrating the health benefits of the drugs beyond losing weight.
Preliminary data is already available: A recent late-stage trial found that Novo Nordisk’s weight loss drug Wegovy reduced the risk of cardiovascular events such as heart attack and stroke by 20%. The results suggest that Wegovy and similar drugs like Mounjaro could have long-lasting heart health benefits.
It is unclear whether Zepbound will eventually encounter supply issues after the U.S. saw widespread shortages of Mounjaro.
On Wednesday, Eli Lilly CEO David Ricks told reporters that the company is prepared to fully launch Zepbound and has the supply to do so. He also noted that all doses of Mounjaro are now listed as available on the FDA’s drug shortage website.
The company is working to boost production capacity for tirzepatide, Ricks added.
“We’re prepared for a big bold launch here toward the end of the year and we’ll work hard to continue to expand our supply capacity to meet the needs of people with obesity,” Ricks told reporters.
Zepbound side effects
Similar to other weight loss drugs, Zepbound is associated with side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, fatigue and allergic reactions, among others, according to the FDA’s approval label.
The agency also noted that Zepbound causes thyroid C-cell tumors in rats, but it’s unclear if the drug has that effect in humans.
The FDA advises against the use of Zepbound in patients with a personal or family history of medullary thyroid cancer – a cancer that forms inside your thyroid gland – or in people with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
The agency also said that Zepbound should not be used in combination with Mounjaro or another weight loss or diabetes drug targeting GLP-1 because “the safety and effectiveness of coadministration” has not been established.
The agency’s other warnings about Zepbound include inflammation of the pancreas, gallbladder problems, acute kidney injury and suicidal behavior or thinking.
“Anti-obesity medications in the past have been associated with suicidal ideation, and that’s really something that should be watched for when you’re treating somebody for weight loss,” Dr. Leonard Glass, Eli Lilly’s senior vice president of global medical affairs for diabetes and obesity, said during a call with reporters. “Therefore we encourage people to keep an eye on this and go to their health care provider for any side effects, they can be monitored.”
FDA approves Eli Lilly drug tirzepatide for weight loss (cnbc.com) |
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| To: Glenn Petersen who wrote (628) | 1/5/2024 8:11:04 PM | | From: Glenn Petersen | | | | Eli Lilly’s direct drug sales alone may not upend the industry, but others could follow suit
PUBLISHED FRI, JAN 5 20242:37 PM EST
UPDATED 5 HOURS AGO
Annika Kim Constantino @ANNIKAKIMC
CNBC.com
KEY POINTS
- Eli Lilly is shaking up the pharmaceutical industry with a new website offering telehealth prescriptions and direct home delivery of certain drugs, such as weight loss treatments, to expand patient access.
- The company’s direct-to-consumer push won’t necessarily upend the pharmaceutical industry and the traditional prescription drug supply chain, according to some analysts.
- But other drugmakers could follow suit with their own direct-to-consumer models and add pressure on what critics call a complex pharmaceutical industry.
Eli Lilly is shaking up the pharmaceutical industry with a new website offering telehealth prescriptions and direct home delivery of certain drugs, including its red-hot weight loss treatment Zepbound, to expand patient access.
The company’s direct-to-consumer push announced Thursday, the first of its kind for a big drugmaker, won’t necessarily upend the pharmaceutical industry and the prescription drug supply chain alone, according to some analysts.
But other drugmakers could follow suit with their own direct-to-consumer models, according to some analysts. That could add more pressure on what many critics call a complex system for distributing, pricing and prescribing drugs in the U.S. — a structure they say has led to higher prices and fewer choices for patients.
“There’s always a possibility for disruption. I think you should never rule out any sort of disruption,” BMO Capital Markets analyst Evan Seigerman told CNBC. “I don’t think that is necessarily happening tomorrow, but I think that you should never assume that things can’t change.”
Lilly’s new platform comes as other companies move to disrupt the drug system in some way, in part as they face more political pressure to cut consumer costs and increase pricing transparency.
Those actions come as lawmakers target drug supply chain middlemen in new legislation and as the Biden administration takes its own steps to rein in prices of medications, such as by giving Medicare the power to negotiate down drug prices for the first time in its six-decade history.
Eli Lilly said its new effort — dubbed LillyDirect — aims to increase access to medicines for chronic diseases, including the highly popular weight loss drugs.
Those treatments, which have soared in demand over the last year as they help patients shed unwanted pounds, are plagued by supply constraints and concerns about potentially harmful knockoffs. Patients also face long waitlists to meet with obesity medicine specialists who can prescribe the drugs to them, a problem Eli Lilly hopes to address, according to Seigerman.
Eli Lilly’s Zepbound won Food and Drug Administration approval just two months ago, but some analysts say it could garner more than $1 billion in sales in its first year on the market.
LillyDirect won’t significantly disrupt the industry
Eli Lilly’s site eliminates the need for a patient to visit the doctor’s office to get a prescription and, in some cases, for a pharmacy to fill it.
But some analysts said Eli Lilly’s site alone will not significantly threaten the traditional drug distribution system, which involves a multitiered network of manufacturers, drug wholesalers, pharmacies and pharmacy benefit managers, or PBMs.
“I don’t think PBMs and the whole infrastructure that we have are going anywhere,” Seigerman told CNBC. “I think what [Eli Lilly] really did was identify some friction points in getting these products [weight loss drugs] to patients, and they’re coming up with a way to solve for that.”
“From my understanding, it’s just that there’s no retail pharmacy where a patient is having to go hunt for that particular [drug] dose, it’s being shipped right to them,” he said of Eli Lilly’s services.
Eli Lilly’s site connects patients with an independent telehealth provider who can prescribe any FDA-approved weight loss drug or other medications for diabetes and migraines. If the prescribed treatment is Eli Lilly’s, the patient can have a third-party online pharmacy deliver it to their door.
Patients will also receive Eli Lilly’s discounts for drugs if they qualify for the company’s savings-card programs, the company noted in a release. One program allows people with insurance coverage for Zepbound, which costs more than $1,000 per month, to pay as little as $25 out-of-pocket. Meanwhile, those whose insurance does not cover the drug may be able to pay as low as $550.
Some experts view that transparent pricing as a shot across the bow to PBMs, the largest of which are owned by CVS, UnitedHealth Group and Cigna.
Drugmakers have long complained that they give PBMs steep drug discounts in exchange for higher placement on a formulary — an insurance plan’s list of preferred medications — only for those middlemen to not pass along savings to patients.
But Eli Lilly’s savings-card program and new site won’t cut PBMs out of the equation.
“If you still use your health insurance to get these drugs through [Eli Lilly’s] website, it’s still going to get processed by a PBM,” Jeff Jonas, a Gabelli Funds portfolio manager, told CNBC.
Patients who get drugs such as Zepbound from Eli Lilly’s site can choose to pay with cash to avoid PBMs altogether. But Bernstein analysts said in a Thursday note that they expect the “vast majority” of potential weight loss drug users to get medications through insurance.
Other drugmakers could follow Eli Lilly
More pharmaceutical companies could adopt a similar approach to Eli Lilly’s.
Cantor Fitzgerald analyst Louise Chen said drugmakers could benefit the most from using a direct-to-consumer pharmacy model for high-selling drugs.
“Cause of the scale of your effort, it [would] probably make sense for bigger drugs,” Chen wrote in an email to CNBC. “You get more bang for the buck and you are reaching more people.”
But Chen said it may be more difficult for a drugmaker to pursue a direct-to-consumer model with smaller, more specialized drugs, such as treatments for complex, chronic, or rare medical conditions. For example, some drugs require specialized training for administration, such as injecting or infusing a therapy into a patient’s vein through an IV.
Drugmakers that do adopt a direct-to-consumer approach could add even more pressure on the nation’s traditional drug supply chain after other companies moved to simplify the system in recent months.
That includes CVS Health, which announced plans to overhaul its business model for pricing prescription drugs in December, adopting a model similar to billionaire Mark Cuban’s direct-to-consumer pharmacy, Cost Plus Drugs. Health-care giant Cigna also announced in November that its PBM will offer a pricing model similar to Cuban’s venture.
Cost Plus Drugs aims to drive down the price of medicines broadly by selling them at a set 15% markup over their cost, plus pharmacy fees.
That company is already shaking up the broader health-care industry: CVS suffered a blow over the summer when a major California health insurer, Blue Shield of California, announced it will no longer use the company as its PBM and instead will partner with several other businesses, including Cuban’s firm and Amazon Pharmacy.
Eli Lilly weight loss drug site may not upend industry (cnbc.com) |
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