Saturday, May 24, 2014
The lesson of today's New York Post Herbalife story
The lesson of this story is that the New York Post at an editorial level - and certainly at the Michelle Celarier level does not believe in anonymity.
Given that journalists rely on anonymous sources for stories this is career dangerous.
Michelle Celarier is now - as far as anyone who thinks journalists should protect anonymity is concerned - damaged goods.
It is so sad to see a journalist self-immolate in the pages of her own paper.
John
PS. For the record I have agreed with the anonymous blogger only sometimes.
Thursday, May 15, 2014
The New York Times pile onto Insys
Interviews with several former Insys sales representatives suggest the company, based in Chandler, Ariz., has aggressively marketed the painkiller, including to physicians who did not treat many cancer patients and by paying its sales force higher commissions for selling higher doses of the drug.
Under F.D.A. rules, manufacturers may market prescription drugs only for approved uses. But doctors may prescribe drugs as they see fit. Over the last decade, pharmaceutical companies have paid billions of dollars to settle claims that they encouraged doctors to use drugs for nonapproved treatments, or so-called off-label uses, to increase sales and profits.
Drug-safety experts said the range of medical professionals who appeared to be prescribing Subsys was troubling, particularly given concerns about the widespread use — and abuse — of narcotic painkillers. In December, Insys disclosed that it had received a subpoena from the federal health department’s Office of the Inspector General for documents related to its sales and marketing practices. The company has said it is cooperating with the investigation.
Marketing the drug off-label is a criminal offence and as the drug has near substitutes it will not be much if any loss to consumers if this company were closed.
The Feds are clearly interested having indicted a doctor who was allegedly prescribing large quantities of the drug off-label.
Can somebody please explain to me why this company is trading at 21 times historic earnings and almost 7 times historic sales? Because I don't quite get it.
John
Tuesday, May 13, 2014
Insys Therapuetics issues a statement
Insys Therapeutics Issues Clarifying Statement
PHOENIX, AZ--(Marketwired - May 12, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY) today issued a clarifying statement regarding its Subsys® (fentanyl sublingual spray) product.
Insys takes patient safety very seriously and we are committed to working with physicians to help ensure the proper prescribing and use of our products.
In terms of our business, we have continually expanded our commercial organization since launch due to the success of Subsys in treating break through cancer pain in opioid tolerant cancer patients who are 18 years or older. As such, we have expanded our prescriber base and for 2014 year-to-date, no single physician has written more than 5% of total Subsys prescriptions.
Based on recent activity, we feel it is appropriate to summarize and address some of the important items regarding Subsys. Subsys is governed by the Transmucosal Immediate Release Fentanyl ("TIRF") Risk Evaluation and Mitigation Strategy ("REMS") Access program, which was approved and launched by the FDA in March 2012. lnsys began commercializing Subsys on March 26, 2012 after the implementation of this TIRF-REMS program.
This TIRF-REMS program is designed to ensure informed risk-benefit decisions before initiating treatment and appropriate use of TIRF medicines. The purpose of the TIRF-REMS program is to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines. Subsys can only be prescribed after physicians have undergone training on the risks and benefits of such products and products can only be dispensed via pharmacies who are REMS enrolled. Additionally, all patients and physicians are required to sign a prescriber patient agreement form as part of this process. Insys continues to support the TIRF-REMS program that was co-developed with other participant companies. More information regarding the TIRF-REMS program can be found at www.tirfremsaccess.com.
Insys does not sell directly to physicians. lnsys only sells Subsys through DEA approved wholesalers who monitor and track prescribing activity for this TIRF class of drugs and all opioids. Insys remains committed to our compliance program and protocols in place that are designed to ensure our sales and marketing practices comply with applicable laws.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative products for supportive care of cancer and pain patients. Using its proprietary sublingual spray technology and its capability to develop pharmaceutical cannabinoids, the company addresses the clinical shortcomings of existing commercial products. The company currently markets two products, Subsys, which is sublingual Fentanyl spray for break through cancer pain, and a generic version of Dronabinol (THC) capsules. The company plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol in the second half of 2014 and believes it is a clinically superior product to current Dronabinol capsules. The company is developing a pipeline of sublingual sprays, as well as pharmaceutical CBD.
Forward-Looking Statements
This press release contains forward-looking statements including the statements related to plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol in the second half of 2014, the Company's belief that this oral liquid formulation of Dronabinol is a clinically superior product to current Dronabinol capsules and the Company's statement regard a pipeline of sublingual sprays, as well as pharmaceutical CBD. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. For a description of these risks facing the Company, please see the risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2013 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
Contact:
Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
I will restrain myself to two things.
(a). They point out correctly they do not sell directly to doctors. No drug company does. Instead they educate doctors about the drug and hopefully the doctors write a script which is collected by the patients. This whole section elides the issue of how the incentive marketing scheme grates against the laws regarding off-label marketing and the like. It is the interaction between the incentive program and alleged off-label prescriptions by the indicted doctor that matter here.
(b). They observe that Subsys can only be prescribed under restrictive conditions... "Subsys can only be prescribed after physicians have undergone training on the risks and benefits of such products and products can only be dispensed via pharmacies who are REMS enrolled. Additionally, all patients and physicians are required to sign a prescriber patient agreement form as part of this process. Insys continues to support the TIRF-REMS program that was co-developed with other participant companies."
This does not match the alleged behaviour of the doctor in question who was allegedly prescribing narcotics for something that looked like carpels tunnel syndrome.
Just saying.
John
Sunday, May 11, 2014
Insys Therapeutics: drug dealers and the Feds. Can the business survive?
We are a commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products. We have two marketed products: Subsys, a proprietary sublingual fentanyl spray for breakthrough cancer pain, or BTCP, in opioid-tolerant patients and Dronabinol SG Capsule, a generic equivalent to Marinol (dronabinol), an approved second-line treatment of chemotherapy-induced nausea and vomiting, or CINV, and anorexia associated with weight loss in patients with AIDS. We market Subsys through an incentive-based sales model.
We launched Subsys as a commercial product in March 2012. Subsys is the fourth new branded product in the TIRF market over the last four years. Within the first four weeks of product launch, Subsys realized greater market share than the previous three branded products combined at their respective peak market penetration levels to date according to Source Healthcare Analytics. In December 2013, Subsys was the most prescribed branded TIRF product with 28.3% market share on a prescription basis according to Source Healthcare Analytics. Through our ongoing commercial initiatives, we believe we can continue to grow our market share and net revenue for Subsys. According to Source Healthcare Analytics, in 2013, TIRF products generated $421.2 million in annual U.S. product sales. The physician prescriber base for TIRF products is concentrated with approximately 1,850 physicians writing 90% of all TIRF product prescriptions in 2013, according to Source Healthcare Analytics. As a result, our commercial organization is able to promote Subsys using a highly targeted approach designed to maximize impact with physicians.
We market Subsys through our U.S.-based, field sales force focused on supportive care physicians. We utilize an incentive-based sales model that employs a pay structure where a significant component of the compensation paid to sales representatives is in the form of potential bonuses based on sales performance.
We commercialize Subsys through a cost-efficient commercial organization utilizing an incentive-based sales model similar to that employed by Sciele Pharma and other companies previously led by members of our board of directors, including our founder and Executive Chairman. We intend to market Dronabinol Oral Solution and other proprietary supportive care products, if approved, using the same approach and our commercial organization.
As of December 31, 2013, we had 145 full-time sales and marketing personnel. We expect the number of our sales and marketing personnel to increase as we seek to continue to increase our existing product sales and as any subsequently approved products are commercialized. We expect our sales and marketing expenses, along with our research and development expenses, to be our largest categories of operating expenses for the foreseeable future. In addition, because we use an incentive-based compensation model for our sales professionals, we expect our sales and marketing expenses to fluctuate from period to period based on changes in Subsys net revenue. Specifically, we expect our sales and marketing expenses to increase in 2014 to the extent that expected increases in Subsys net revenue are realized.
Very wrong of course is off-label selling and diversion to drug addicts. Worse still is the systematic creation of drug addicts by your sales force who are paid by incentives.
Medicare paid Awerbuch [the allegedly corrupt doctor] $6.9 million from Jan. 1, 2009, through Feb. 6, 2014, for Subsys he prescribed. The next highest amount a U.S. prescriber received was $1.6 million.
"Awerbuch is responsible for approximately 20.3 percent of the Subsys prescribed to Medicare beneficiaries nationwide during this time," the affidavit stated.
He wrote 1,283 prescriptions for the drug in five years, while the next closest prescriber wrote 203 prescriptions, the complaint stated.
On one visit, an undercover officer asked for a Vicodin prescription and attempted to bribe Awerbuch for the drug with $1,000. The officer told Awerbuch he would sell the drug to coworkers.
Awerbuch refused the bribe and asked the officer not to sell Vidodin again. He also asked if the officer was a Drug Enforcement Administration for FBI agent. The officer said he was not, and Awerbuch issued him the Vicodin prescription.
During a later visit, Awerbuch proscribed Subsys to the officer even though the officer had not been diagnosed with cancer.
Just in passing the affidavit mentions prescriptions to individual patients. They go up very rapidly consistent with addiction. If you want the bull case for the company that is it. Rapid growth based on addiction.
Diversion
It is much easier for a narcotics user to prepare a sterile liquid for IV use than a medicated lollipop. I have a pet suspicion - not proven - that one reason for the very rapid uptake of the spray version is that it is much more suitable for diversion.
We have
(b) a drug that seems designed for diversion,
(c) an incentive system for sales people that encourages them to make sales regardless and who - because of their incentives - may be tempted to sell off label,
(d) a single doctor who prescribes a double-digit percentage of the Medicare total for the drug and who is currently under indictment.
Finally we have (e) a drug with perfectly good substitutes such that the loss of the company marketing the drug will mean no real loss to society or patients.
Oh, and the company is trading at a big multiple of sales and of earnings.
Thursday, May 8, 2014
Further explanation re Gulfports quarterly guidance
General observation: it has been widely observed that the single best measure of an oil and gas company management is their finding and development costs. Warren Buffett has made this observation many times.
Here - from fairly recently - 26 February this year - is their guidance for production and capital expenditures for this year.
Year Ending | ||
12/31/2014 | ||
Forecasted Production (BOE per day)
| ||
Utica
| 44,500 - 54,500 | |
South Louisiana
| ~5,500 | |
Average Daily Oil Equivalent
| 50,000 - 60,000 | |
Total Equivalent - MMBOE
| 18.25 - 21.90 | |
Projected Cash Operating Costs per BOE
| ||
Lease Operating Expense - $/BOE
| $2.00 - $3.00 | |
Transportation, Processing & Marketing - $/BOE
| $2.50 - $3.50 | |
Production Taxes - % of Revenue
| 4% - 6% | |
General and Administrative - $/BOE
| $1.25 - $2.25 | |
Interest - $MM/Quarter
| $4.0 - $4.5 | |
Depreciation, Depletion and Amortization per BOE
| $21.00 - $24.00 | |
Budgeted Capital Expenditures - In Millions:
| ||
Utica
| $594 - $634 | |
Southern Louisiana
| $66 - $71 | |
Grizzly
| $15 - $20 | |
Total Budgeted E&P Capital Expenditures
| $675 - $725 | |
Budgeted Leasehold Expenditures - In Millions:
| $225 - $275 |
Quick summary: they intended to spend $675 to $725 million in capital expenditures and by year end their flow rates would be 50-60 thousand barrels per day.
From yesterday here is their guidance:
Year Ending | ||
12/31/2014 | ||
Forecasted Production (BOE per day)
| ||
Utica
| 31,500 - 36,500 | |
South Louisiana
| ~5,500 | |
Average Daily Oil Equivalent
| 37,000 - 42,000 | |
Total Equivalent - MMBOE
| 13.51 - 15.33 | |
Projected Cash Operating Costs per BOE
| ||
Lease Operating Expense - $/BOE
| $3.50 - $4.50 | |
Transportation, Processing & Marketing - $/BOE
| $3.50 - $4.00 | |
Production Taxes - % of Revenue
| 4% - 6% | |
General and Administrative - $/BOE
| $1.50 - $2.50 | |
Interest - $MM/Quarter
| $4.0 - $4.5 | |
Depreciation, Depletion and Amortization per BOE
| $21.00 - $24.00 | |
Budgeted Capital Expenditures - In Millions:
| ||
Utica
| $634 - $676 | |
Southern Louisiana
| $66 - $71 | |
Grizzly
| $15 - $20 | |
Total Budgeted E&P Capital Expenditures
| $715 - $767 | |
Budgeted Leasehold Expenditures - In Millions:
| $375 - $425 |
We now intend to spend more - $715 to $767 million - that is more - and we intend to produce only 37-42 thousand barrels per day - substantially less.
They also plan to spend more on buying additional leasehold. Historically they have purchased all this leasehold from related parties.
So far the company has had many capital raises based on considerably more bullish guidance.
A considerable amount of the money raised has wound up in the hands of Gulfport's related parties as per the related party statement quoted below.
Are you comfortable?
John
===========================
Gulfport Energy's (GPOR) guidance
Tuesday, May 6, 2014
Just how weak are Bill Ackman's examples?
Ackman's websites however are truly strained. Here is a section from his profile of distributor Michael Burton. I am quoting verbatim:
The Burtons’ businesses do considerable damage to consumers. Consumer complaints regarding Global Home Business Systems, for example, are particularly revealing:
- One complaint, from an individual who purchased the GHBS “starter pack” in order to “become part of the Herbalife Company,” cites the extreme difficulty of connecting with a GHBS employee who was supposed to assist in setting up that individual’s Herbalife business. The complaint notes that it had been one month of “phone tag” and cancellations without any contact from the GHBS employee, despite the fact that “[GHBS] claim[s] that the whole program is up and running within 2 weeks.” See http://www.ripoffreport.com/r/Global-Home-Business-Systems-HerbalifeElaine-Depinto/internet/Global-Home-Business-Systems-Herbalife-Elaine-Depinto-company-rip-off-complete-waste-of-453259.
- Another complaint from a GHBS customer notes that “they told me that to weed out the peoiple [sic] that really wanted to work they were charging $9.95 shipping for the video. [A]nd when you get the DVD I viewed the DVD and there was noting [sic] there to help me start a buisness [sic] [in] Los Angles California.” See http://www.ripoffreport.com/r/global-home-business-systems/los-angles-california-/global-home-business-systems-they-told-me-that-to-weed-out-the-peoiple-that-really-wanted-462221.
End quote:
Please read these links. In the first one the person has been ripped off for $9.95 - and not $9.95 he paid to Herbalife. The $9.95 was paid to Burton.
In the second link it was $50 - but there is considerably less documentation.
This constitutes, and I am quoting Ackman's site again: "considerable damage to consumers".
Seriously - this is the strength of material on which he has bet his reputation and the existence of Pershing Square. I have a staff member who I recruited from America and whom Verizon Wireless charged $15 for data consumed after he had left the country. On this basis I encourage a billion dollar bet against Verizon...
By contrast, every distributor in Ackman's documentary lost serious amounts of money - but the money lost was not lost to Herbalife. It was lost to distributors Herbalife has now sacked. It seems -- that at least with respect to the material in the documentary Ackman is fighting yesteryear's battles.
John
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