AMLN - comments?

[jiesen]

Jiesen,
I am selling out of the money calls, and as the stock moves South, I cover those calls. Then as the stock moves up, I again sell the calls. Example: AMLN was about $46.50 the other day, and I sold the JAN $45 for $7.20. AMLN pulled back for three days, and those calls dropped down to $5.90. Covered them and I am looking to resell those calls again, though this time I am looking at the $50 strike. IF AMLN climbs to $50 and never looks back, I will still be happy with my profits. But AMLN moves around alot, and I like that, because the options are pretty hefty.

Thanks for recommending this stock back when it was $21.

NBB,
I'm glad you like the stock, and hope you make a ton of $$ on the options! You're right, AMLN is pretty volatile, which can make for some juicy profits there.

[jiesen]

check this out - another possibility for AMLN's drug

from a post at IV:

http://www1.investorvillage.com/smbd.asp?mb=2885&mn=4627&pt=msg&mid=343887

In yet another ongoing clinical trial, Amylin is testing exenatide as a treatment for Polycystic ovary syndrome...a condition that evidently affects 5-10% of all women of reproductive age. What follows is a brief explanation of the condition of PCOS as background, followed by the Phase 2 Clinical trial sponsored by Amylin in conjunction with the Lousiana Research Foundation, which began recruiting in June, 2006.

Assuming succesful results of this trial, Byetta label expansion for treatment of PCOS would expand potential users into a population of up to 5-10% of all women...who otherwise would be under threat of reproductive problems, long term diabetes and heart disease.
*******

Introduction
Polycystic ovary syndrome (PCOS) is a condition most often characterized by irregular menstrual periods, excess hair growth and obesity, but it can affect women in a variety of ways. Irregular or heavy periods may signal the condition in adolescence, or polycystic ovary syndrome may become apparent later when a woman has difficulty becoming pregnant.

The signs and symptoms of polycystic ovary syndrome stem from a disruption in the reproductive cycle, which normally culminates each month with the release of an egg from an ovary (ovulation). The name polycystic ovary syndrome comes from the appearance of the ovaries in some women with the disorder — large and studded with numerous cysts (polycystic). These cysts are follicles, fluid-filled sacs that contain immature eggs.

Polycystic ovary syndrome is the most common hormonal disorder among women of reproductive age in the United States, affecting an estimated 5 percent to 10 percent. Early diagnosis and treatment of polycystic ovary syndrome can help reduce the risk of long-term complications, which include diabetes and heart disease.
************************************************** ******************
Exenatide and Metformin Therapy in Overweight Women With PCOS

This study is currently recruiting patients.
Verified by Metabolic Center of Louisiana Research Foundation June 2006

Sponsors and Collaborators: Metabolic Center of Louisiana Research Foundation
Amylin Pharmaceuticals
Information provided by: Metabolic Center of Louisiana Research Foundation
ClinicalTrials.gov Identifier: NCT00344851


Purpose

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.
Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: metformin, exenatide or combined (metformin & exenatide )
Phase II


MedlinePlus related topics: Ovarian Cysts


Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Comparison of the Effects of Monotherapy With Exenatide or Metformin to Combined Exenatide and Metformin Therapy on Menstrual Cyclicity in Overweight Women With Polycystic Ovary Syndrome

Further study details as provided by Metabolic Center of Louisiana Research Foundation:
Primary Outcomes: - Menstrual Cyclicity ( # menses/ 24 weeks)
Secondary Outcomes: BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,; insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),; and pancreatic ß-cell function (corrected insulin response [CIRgp] and; insulinogenic index [IGI] ).
Expected Total Enrollment: 60
Study start: June 2006


Objectives: The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with exenatide and metformin alone, to combination therapy in women with PCOS. This study will serve as a pilot investigation to open perspectives for future investigations combining insulin-sensitizing drugs with different mechanisms of action in patients with PCOS, especially ones for whom standard treatment with metformin is less effective.

Subjects : 60 oligomenorrheic overweight/obese (BMI >27) women meeting criteria for PCOS (age 18-40)· six or fewer menses /year or amenorrheic· clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T))· PCOS ovary on ultrasound(need to meet criteria 1 and either 2 or 3 [or both]) Inclusion/Exclusion Criteria: Major EXCLUSION CRITERIA – FEMALE1) other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia2) presence of overt diabetes or impaired glucose tolerance3) alterations in hepatic or renal function4) use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks5) Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug6) Simultaneous participation in another clinical trial7) Known active substance abuse including tobacco and alcohol. (> 10 cigarettes/day) Refusal or inability to comply with protocol9) patient desiring pregnancy, pregnant, or breastfeeding Study Design: Balanced randomized parallel group clinical study with 3 treatment arms: metformin (1000 mg BID); exenatide (10 mcg BID) or combined (metformin 1000 mg BID; exenatide 10 mcg BID) therapy for 24 weeks.

Efficacy Measures: Primary- Menstrual Cyclicity ( # menses/ 24 weeks)Secondary-BMI, WHR, FAI (T/SHBG), DHEAS, lipids, insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT), and pancreatic ß-cell function (corrected insulin response [CIRgp] and insulinogenic index [IGI] ).

Safety: For safety, all subjects who enter the study are evaluable. Subjects will be monitored for safety by assessment of adverse events, physical exams, vital signs and laboratory values.

Statistical methods/analysis: The measurement of menstrual frequency involves nominal data ( patients with/without regular cycles pre vs post-treatment and will be analyzed using the McNemar test (complex chi square for paired data). For all other analyses, in which the data are interval, parameters, such as androgens, lipids, insulin sensitivity, etc. will be evaluated using a SS/Treatment x Trials (pre/post) analyses of variance (ANOVA). This repeated measures design will allow us to determine if each of the treatment drugs had an effect and if they are significantly different from each other while controlling for individual patient differences Study Drug Regimens: Exenatide5 ug bid - 4 weeks10 ug bid - 20 weeks (end of study)Metformin500 mg qd 2 weeks500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks1000 mg bid –18 weeks (end study) Exenatide plus MetforminExenatide- 5 ug bid-4 weeksMetformin 500 qd for 2 weeks, 500 mg bid 2 weeksExenatide- 10 ug –20 weeks (to end of study)Metformin-500 mg am, 1000 mg pm- 2 weeks – 1000 bid for 18 weeks (end of study)** Metformin may be adjusted at the discretion of the physician to a level that is tolerable in patients who cannot tolerate the full dose of metformin in combination with exenatide (combination therapy only )
*******************

http://www.clinicaltrials.gov/ct/show/NCT00344851?order=14

Java

[jiesen]

blowout scrip numbers!

Prescriptions for Byetta rose this week to 48692 from 43948 last week. We are finally seeing the end of the supply bottleneck. Now is the time to load up on AMLN, as the stock price must catch up to the rising revenues again!

http://www1.investorvillage.com/smbd.asp?mb=2885&mn=5668&pt=msg&mid=416729

[peanuts]

Prescriptions for Byetta rose this week to 48692 from 43948 last week. We are finally seeing the end of the supply bottleneck. Now is the time to load up on AMLN, as the stock price must catch up to the rising revenues again!

http://www1.investorvillage.com/smbd...msg&mid=416729

Jiesen,

Why does AMLN lose money? They have a negative EPS according to Stockcharts. Will these increased revenues make the company profitable?

Thanks. I'm looking for new LT investments. As I have to rebalance my portfolio, now.

[jiesen]

AMLN has lost money up until now because they've never had a product until about a year ago (now they have 2 on the market and more to come). The products which they do have, haven't attained sufficient market share to make the company profitable as a whole, but they will. It will likely take another year or two for that, but I have no doubt that Byetta will be making a billion a year or more by 2008. Right now, it's running about $500M/year but like I just posted, there was a 10% increase just in the last week in prescriptions and therefore revenues. And with an 86% gross profit margin

see my previous post: http://www.mrmarketishuge.com/showth...?t=899&page=21

you can bet that increased revenues will increase the profitability of AMLN.

[peanuts]

you can bet that increased revenues will increase the profitability of AMLN.

It will reduce losses. I feel a little iffy on this, dude... It would be one thing if they were already profitable and then started to make even more money, but if they are just reducing their losses, then the net result is basically the same- the company is still in the red. To me, that means the share price should erode with the losses on the books. I understand that the margins seem good now, but what about when sales take off? Will the selling costs as a percentage of sale increase at a faster rate than sales? On the surface, it sounds like this will be the case, since the products are relatively new...

Keep me updated, please. I hope you do really well with it and get another one of those HUUUUUGE 120% trades!!!

[jiesen]

some good advice on biotech investment

http://www.forbes.com/2006/09/26/fda-drug-approvals-stocks-biz_cx_pk_0927fda.html?partner=yahootix

Stock Tips From The FDA
Matthew Herper and Peter Kang 09.27.06, 6:00 AM ET

The colon cancer drug Vectibix is one of the most promising medicines being developed by Amgen, the world's largest biotech firm. The antibody, infused into patients veins', is similar to ImClone's Erbitux but causes fewer allergic reactions. Annual sales could top $800 million three years from now--if the U.S. Food and Drug Administration decides to approve it.

Investors don't know what the FDA will decide, but they know when the decision will come: by Thursday. Why? A 1992 law sets deadlines for such decisions, by which the FDA must approve, delay or reject outright a new drug. And according to recent research from the investment bank Sanford C. Bernstein, those dates should help determine when investors buy drug and biotech stocks--and when they decide to sell them short.
In Pictures: Upcoming Regulatory Decisions

The 1992 law, the Prescription Drug User Fee Act (PDUFA), was a bargain made by industry to speed up drug approval times. Drug companies agreed to pay fees when they submitted new medicines for review, and are now paying the FDA $250 million a year. In return, the agency would make its decisions on strict time lines: drugs that were determined to be of vital medical need would face a six-month review; other decisions are given ten months.

Companies generally issue press releases when a drug is accepted for regulatory review, and when they don't, investors clamor for them. The result: Drug firms, their rivals and their stockholders mark their calendars with the expected PDUFA date for a new drug. Shorts and longs alike converge on biotechs as the date approaches, knowing the stock could get a bump from regulatory action or drop precipitously when the FDA tells a biotech to do more homework.

But is playing PDUFA dates smart? Maybe not, if you're a bull or a long-term investor. Analysts at Sanford C. Bernstein have looked at how shareholders in big pharmaceutical and more volatile biotech stocks have done over the past couple of years when they bet ahead of regulatory decisions. "It hasn't paid to be early," writes Richard Evans, Bernstein's U.S. pharmaceuticals analyst.

Evans found 56 positive and 46 negative decisions. In all, the negative FDA decisions hurt the share price more than the positive decisions helped it. Moreover, the FDA decisions tended to influence the share price long after they were made. Getting past the FDA often led companies to months of outperformance.

The lesson: Use FDA decisions as a way to scout out new investments, not as an event to trade on. Even after a stock has popped from the approval of a new drug, there is still room for the stock to run. Amylin Pharmaceuticals (nasdaq: AMLN - news - people ) and marketing partner Eli Lilly (nyse: LLY - news - people ) got their diabetes drug, Byetta, past the FDA on April 29, 2005. Shares actually fell the next day, but then broke out in late August on strong Byetta sales and good data for a still unapproved, long-acting form of the drug.

In fact, there might be an upside in shorting ahead of a regulatory decision, when bad news is most likely to arrive. This is particularly true, Evans said in an e-mail, if the FDA is rejecting or delaying a lot of drugs, because negative events tend to hurt more than positive ones help share prices. "Most times you would lose a little money, but sometimes you would gain a lot," says Geoffrey Porges, a biotech analyst at Bernstein who didn't work on the current report but has drawn similar conclusions in the past.

Two years ago, Porges also found that betting on drug stocks ahead of PDUFA dates was risky, but doing so ahead of expected data announcements was somewhat less so. This was especially true of big biotechs like Amgen (nasdaq: AMGN - news - people ) or Genentech (nyse: DNA - news - people ), where earlier clinical trials usually allowed investors to predict how later ones would turn out.

As for the PDUFA strategy, investors will have plenty of chances to put it in place--both by shorting weaker biotechs and betting on the good ones after approval. On Friday, a decision is expected on a lucrative new indication for the cancer drug Rituxan, from Genentech. Decisions on two diabetes drugs from Merck (nyse: MRK - news - people ) and Novartis (nyse: NVS - news - people ) are expected next month. All told, we count at least 11 expected decisions through the beginning of next year.

[jiesen]

http://members.cox.net/mystock/Amylin.htm

where does it look like these scrip numbers for Byetta are heading? right now a 50k week means a $50 stock. but next year, when AMLN does 80k/week Byetta scrips, where will the stock trade?

take a look at the scrips chart- second tab. AMLN is going there... and then some.

[billyjoe]

Jiesen,
What is your take on DNA's avastin? Is it as potentially huge as the statin drugs? Are they really marketing it under different names and strengths and using to treat a variety of ailments , charging wide ranges of prices for the same product ?

----------billyjoe

[jiesen]

Jiesen,
What is your take on DNA's avastin? Is it as potentially huge as the statin drugs? Are they really marketing it under different names and strengths and using to treat a variety of ailments , charging wide ranges of prices for the same product ?

----------billyjoe

Billyjoe,

I really dont know much about avastin's situation, but I will try to find out about it. marketing under different names does seem to be par for the course these days in the drug market.

I know that DNA is premier biotech company, one of just a few making decent money right now. I would be interested in this one if I werent already so heavily into biotech already. If AMLN hit 80 tomorrow, I might sell it and take a closer look at DNA though.

if you want a good safe biotech position, best bet would be to split your money in DNA and AMGN, then forget about it, imo. you have a good point in the avastin question, though, since it is a significant chunk of DNA, you would definitely want to be sure that it'll do well over the next few years before committing to DNA.

[jiesen]

results are in - AMLN beats estimates by 0.10

Well, the revenues were about where I expected, at $147M (up about 500%), but they did a much better job on the EPS than I thought, trimming it to just 0.36 from 0.65 this time last year. With sales continuing to increase and a 90% gross margin, they could turn this loss around to a profit as early as next year, imo.

http://biz.yahoo.com/ap/061018/earns_amylin.html?.v=1

Amylin 3Q Loss Narrows on Byetta Sales
Wednesday October 18, 5:30 pm ET Amylin Pharmaceuticals Cuts Its Third-Quarter Loss and Beats Expectations As Byetta Sales Grow

SAN DIEGO (AP) -- Drug developer Amylin Pharmaceuticals Inc. said Wednesday its third-quarter loss narrowed 34 percent, as sales jumped fivefold, soundly beating Wall Street expectations. The company reported a net loss of $46.1 million, or 36 cents per share, compared with a loss of $69.5 million, or 65 cents per share, a year ago. Analysts polled by Thomson Financial, on average, expected a loss of 46 cents per share.

Revenue jumped to $147 million from $25.9 million. That also topped Wall Street estimates, as analysts expected revenue of $136.6 million.

The jump came from sales of the diabetes drugs Byetta and Symlin. Byetta sales made up the bulk of revenue, totaling $126.4 million. Analysts were worried about whether the drug could recover from a moratorium on new prescriptions, imposed after demand far outpaced supply of the cartridges that hold the injectible drug. That moratorium was lifted during the quarter as the company added a second supplier to keep up with demand.

Amylin and drug developer Eli Lilly & Co. are partners on Byetta.
Symlin sales made up $12.4 million of Amylin's revenue. Collaborative agreement payments brought in another $8.2 million, which double the previous year.
Shares of Amylin rose 41 cents to close at $47.45 on the Nasdaq during regular trading. They continued to rise after hours, gaining 79 cents to reach $48.24 on the INET electronic exchange.

[peanuts]

Well, the revenues were about where I expected, at $147M (up about 500%), but they did a much better job on the EPS than I thought, trimming it to just 0.36 from 0.65 this time last year. With sales continuing to increase and a 90% gross margin, they could turn this loss around to a profit as early as next year, imo.

I see that some analysts were expecting a loss of .46. AMLN really thumped those estimates. This may bode well for the stock price...

good luck

[New-born baby]

I see that some analysts were expecting a loss of .46. AMLN really thumped those estimates. This may bode well for the stock price...

good luck

Yeah, it could jump today. Still tradin' at more than 10X sales.

[jiesen]

Yeah, it could jump today. Still tradin' at more than 10X sales.

yes, but the current 500% sales growth does count for something

[New-born baby]

yes, but the current 500% sales growth does count for something

Yes, indeed it does!