Feature
| SATURDAY, OCTOBER 19, 2013
Too Close for Comfort?
By BILL ALPERT | MORE ARTICLES BY AUTHOR
Drug company Questcor is both a donor and a beneficiary of a fast-growing medical charity. That could give investors aches and pains.
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Off-duty cops secured the meeting rooms at the Gaylord Texan Resort last month, as the Chronic Disease Fund held its yearly conference at the Dallas-area hotel. Days before, the medical charity had canceled the registrations of some would-be attendees and refunded their $1,500 donations. The uninvited then got threatening lawyers' letters fromQuestcor Pharmaceuticals, a drug company that's been a backer of the charity and a bug zapper for short sellers.
Questcor's letters said the barred guests must have bought tickets for the charity's fundraiser and conference to get nonpublic information and manipulate Questcor stock (ticker: QCOR). Those letters, which several Wall Street recipients showed to Barron's, told the interlopers to prepare for litigation and to stop contacting the Chronic Disease Fund and its affiliates.
How Questcor learned the registrants' identities is a mystery that neither it nor the charity would explain. The Plano, Texas-based CDF has quickly become one of the country's largest medical charities, its annual receipts surpassing those of better-known groups such as the Susan G. Komen Foundation, which is dedicated to the treatment of breast cancer, or the March of Dimes, which focuses on preventing birth defects. Regulatory filings suggest that Questcor and the CDF owe some of their success to one another.
From 2007 through 2012, the Chronic Disease Fund's tax returns show that it pulled in donations of more than $900 million, mostly from drug companies like Questcor. The CDF has made a rich man of the charity's founder and president—46-year-old Mike Banigan. Over the same stretch, the CDF paid more than $35 million for "data-processing" services to a firm that's one of many health-care companies that share offices with the charity and are owned by Banigan. In a section of its 2012 return not shown on its Website, the charity says that last year it bought the data-processing business outright from a Banigan-related trust, for an $18 million lump sum, plus monthly payments of $1 million that could add significantly to his take.
The Chronic Disease Fund is the largest of a half-dozen nonprofit "patient-assistance programs" that have emerged in recent years to help patients meet the steep co-payments that insurers require for some expensive drugs. President Obama's health-care law will expand the ranks of those with health insurance, but that may also increase the number of those enrolled in high-deductible health plans. Co-pay-assistance programs were pioneered by charities like the National Organization for Rare Disorders to improve access to expensive new therapies that can be the only effective treatments for some rare cancers and other dire illnesses.
CDF's Website shows that it works with numerous drug makers, from Roche's(ROG.Switzerland) Genentech to Novartis (NVS), but few companies would seem to need its co-pay programs as much as Questcor. The Anaheim, Calif., company's only marketed product, Acthar, is a 60-year-old, naturally derived substance that it acquired in 2001, raised in price by 1,000% and now sells mostly for illnesses that can also be treated with synthetic steroids like prednisone at 1/100th the price of a $6,000 Acthar injection. A risk for Questcor is that doctors and patients would abandon Acthar for generic alternatives without the CDF programs that defray the thousand-dollar co-pays.
Questcor spokesperson Janine McCargo said in an e-mail that the company's management is "disinclined to do interviews" and prefers to "let results themselves prove or disprove theories."
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Questcor's collaboration with the CDF is one of many savvy moves in the past six years that helped lift its shares from pennies apiece to a recent price of $65.80. As shown in the chart "Percentage of Questcor's Gross Sales," Questcor also has increased Acthar sales in government-funded channels like the military health-care program Tricare, as well as Medicare and Medicaid.
It's easy to see why some folks like Questcor's stock. The company has grown sales and earnings lately at an annual rate above 60%. Still, the shares trade at less than 16 times the trailing 12 months' earnings of $4.17. Management returns cash to shareholders through buybacks and a recently raised dividend that amounts to a 2% yield. But it's also easy to see why some curmudgeons have shorted 25% of Questcor's free-trading float. Questcor has disclosed that its promotional practices have been under investigation since 2012 by federal prosecutors in Philadelphia, with whom the company's cooperating. Acthar sales could also take a hit from new initiatives to curb the high-priced drug's use within Tricare and Medicare. To date, the shorts have paid a big price for their skepticism: the stock has risen 4,000% in the past six years. Barron's was among the skeptics ("Medical Marvel," Feb. 7, 2011).
As successful as Questcor has been at helping patients obtain Acthar, the co-pay arrangement with the CDF carries its own risk. Like most co-pay charities, the CDF displays an advisory letter on its Website (cdfund.org) from the Office of the Inspector General of the Department of Health and Human Services, which discusses whether the financing of the co-pay program by drug companies constitutes kickbacks to induce doctors and patients to utilize drugs that are unnecessary or more expensive than equivalents. The OIG's September 2006 advisory letter said the agency wouldn't challenge the CDF's program, as long as drug-company donors didn't influence the charity's choice of targeted diseases and a drug maker's contributions weren't earmarked for its own products.
How well the CDF has abided by those commitments is a fair question, given that eight of the 37 disease states for which the CDF Website says it is enrolling patients are diseases for which Acthar is the only drug on the charity's list of approved therapies—even though branded and generic alternatives for those diseases are on the market.
Questcor spokesperson McCargo says the company donated $3.1 million to the CDF for co-pays in the June 2013 quarter. If patients averaged a 10% co-pay, that would correspond to about $125 million in annual retail sales. She says Questcor has also provided a total of $360 million worth of free Acthar through the National Organization for Rare Disorders. The company's never explained how it distributes all those free vials, which contain five doses and have a value of $30,000 each.
When Questcor raised the price of a vial of Acthar from $1,650 to $23,000 in 2007, the drug was mainly used to treat infantile spasm, a rare kind of seizure afflicting babies, for which Acthar is a standard treatment.
Infantile syndrome is now a small part of Acthar's value to Questcor. The drug label has 18 other disease indications. Questcor's net sales more than doubled last year, topping $500 million, while earnings grew 150%, to about $200 million, or $3.14 a share. At an investor conference last month, the company estimated that 10% of Acthar sales were for infantile spasm, 30% for multiple sclerosis, 40% for a kidney disease, and 18% for arthritis and related illnesses.
After the co-pay, a course of Acthar treatment for some of these ailments can cost insurers or the government hundreds of thousands of dollars.
Questcor doesn't disclose what portion of Acthar sales go to patients covered by commercial insurance or government programs like Medicaid, but in its financial statements it must reserve for the various price rebates the government is allowed. By analyzing these reserves, Barron's estimates that taxpayers footed the bill for almost half the company's gross sales (that is, before rebates) in the six months ended June 2013, up from about 40% in the corresponding year-earlier period.
There has also been a seemingly sharp recent rise in sales to patients covered by Medicaid and the military's Tricare. Tricare beneficiaries make up about 3% of Americans with health coverage, but Tricare sales seem to have risen this year to 5% of Questcor's total. Records of Tricare's Acthar claims, released pursuant to a Freedom of Information request, show the drug being prescribed by a South Carolina dentist and orthopedic surgeons (who didn't respond to our queries). The apparent jump in Acthar usage among the Medicaid population correlates with a reduction in the government's rebate that made Medicaid sales of Acthar profitable for the first time to Questcor.
It may become harder to boost Acthar sales through government channels. In a meeting last month, Tricare's medical advisory panel recommended that the program not cover Acthar for arthritis and to provide it for multiple sclerosis and kidney treatment only upon appeal.
Also in September, three of Medicare's 10 regional administrators excluded Acthar from coverage under the Medicare Part B program for outpatient medical services, because most patients administer the drug themselves. Yet Part B submissions totaled about a quarter of Medicare claims for Acthar, according to insurance-claims databases thatBarron's reviewed.
Ever since Medicare added its Part D drug benefit, the program's guardians have worried about drug companies subsidizing a patient's co-payment to induce an expensive Medicare drug claim. In a 2005 advisory bulletin, the OIG warned co-pay charities against defining disease categories so narrowly that the earmarking effectively results in the subsidization of the donor's particular products. At the time that Questcor filings first mentioned the CDF, the charity already had a program for multiple sclerosis drugs. Still, the CDF launched a program for "acute exacerbations of multiple sclerosis"—language that echoes the label of Acthar, but not those of other drugs on the CDF's roster. CDF Executive Director Clorinda Walley in a Friday e-mail confirmed that the sole drug supplied under that co-pay program was Acthar.
"We follow the OIG guidelines," said the charity's outside counsel Tom Fox, of the Washington law firm Reed Smith. "There is no steering that takes place whatsoever."