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Biotech Stock Mailbag: Spectrum Pharma

Even after sifting through SEC documents, company press releases and its Web site, it seems that Generex has not recorded significant revenue from Oral-lyn sales in any of the four countries -- Ecuador, India, Lebanon and Algeria -- where the company claims to have approvals in place. Moreover, Generex now concedes that Oral-lyn revenue is even further delayed:

"... we do not anticipate significant revenue from sales of Generex Oral-lyn in India in calendar year 2010, as we have to complete an in-country clinical study before the product can be offered for commercial sale. We also have entered in subdistribution agreements in Lebanon and Algeria but do not expect any significant revenue from the launch of the product in those countries in calendar year 2010," according to Generex's most recent 10-Q filing. (Emphasis mine.)

That's a change from Generex's 10-Q filed for the Jan. 31 quarter in which the company stated, "... we do not anticipate significant revenue from the initial commercial launch of Generex Oral-lyn in India until sometime this fiscal year. " (Emphasis mine.)

Generex's fiscal year ends July 31, 2010.

More nuggets from Generex's latest 10-Q:
  • Efforts to get Oral-lyn approved in Syria are delayed because the Syrian government requested Generex conduct an in-country clinical trial.
  • Generex has submitted Oral-lyn for approval in Bangladesh, Kenya, Yemen, Iraq, Iran, Libya and Sudan.

    My (admittedly snarky) comment: Generex looks to be cornering the Axis of Evil market with Oral-lyn, although there is still no word on the timing of the company's North Korean filing. Wait a second... hasn't it been reported that Osama bin Laden is a diabetic? Hmmm, makes you wonder.
  • In the last quarter, Generex awarded 1.75 million stock options to executives, directors and management employees with a fair value of just over $1 million.

    Me: Good for Generex's executives, not so much for Generex shareholders. For those keeping score at home, Generex's stock price fell 29% to 45 cents a share in the same time period. Since the fiscal quarter ended, Generex shares have sunk further and are now trading at 34 cents a share. The company faces delisting from Nasdaq unless shareholders approve a reverse stock split.
  • As for Crave-NX, Generex's diet glucose spray sold in drugstores and convenience stores, the company is being sued by a woman in California who alleges she was misled by the product's advertised weight-loss claims. Generex, in its SEC filing, says the company intends to fight the lawsuit.
  • Generex posted revenue of about $328,000 from its over-the-counter glucose and energy sprays in the April 30 fiscal quarter, up from revenue of $45,000 one year ago. But on a sequential basis, Generex's revenue in the recently closed quarter was down 24 percent from $431,000 in revenue in the Jan. 31 fiscal quarter.

Mark M. emails, "I have followed many of your articles on Dendreon (DNDN). I have owned Dendreon for a few years now and, while I am very optimistic overall, I have one major concern and question: What is the likelihood of Dendreon getting reimbursement from the insurance industry and Medicare that is close to what their price for Provenge treatment is? Any word on this yet?"

No cancer drug approved on the basis of a survival benefit has ever been denied insurance reimbursement (private or Medicare) in the U.S. I don't see any reason for Provenge to be the first exception to that rule. The Provenge launch is in the early days, but Dendreon has told investors that doctors are receiving prior authorization from insurers for Provenge coverage, even if actual checks have not yet been cut. Insurers, including Medicare, can take up to three months to pay claims; Provenge has only been available for about a month. Dendreon has in place financing programs to help doctors and patients cover the reimbursement gap and co-pays.

Regardless, Wall Street's concerns about Provenge reimbursement will not be quelled until insurers cut real checks, doctors deposit the money into their accounts, then use it to buy their wives or mistresses more plastic surgery. OK, maybe that last part isn't necessarily true, but you get the idea.
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