Dendreon can’t reap the full potential of its pioneering treatment for prostate cancer until it gets more manufacturing capacity built up, but it’s making enough progress to project how this supply-constraint story will play out over the coming year.
The Seattle-based biotech company (NASDAQ: DNDN) said today that it generated $20.2 million in the most recent quarter which ended on September 30. Demand for the drug, sipuleucel-T (Provenge) climbed each month during the quarter, and kept climbing until the company essentially maxed out its current capacity with $9.5 million in sales in October.
Dendreon’s ability to handle this manufacturing shortage is critical, as prostate cancer patients, physicians, shareholders, and many other aspiring immunotherapy companies will be hugely disappointed if it can’t solve the shortage on schedule. The company, which won FDA approval of the first-of-its-kind immune boosting therapy for prostate cancer in April, reaffirmed that it is spending $460 million in cash this year as it gets fully equipped with factories in New Jersey, Atlanta, and Los Angeles. Based on projections of demand from patients, and the company’s projected supplies, the company now expects to sell $350 million to $400 million worth of Provenge in 2011, with about half of that coming in the final three months of next year, when its factories will be operating at full tilt.
As I’ve written in this space many times, Dendreon’s drug isn’t as simple as a pill in a bottle or a liquid in a vial. It’s based on an intricate process in which blood is withdrawn from a patient, and certain immune system cells get “taught” to recognize markers of prostate cancer like a foreign invader. The cells are shipped to a Dendreon factory, where they get revved-up to fight cancer, and shipped back for re-infusion into the patient.
“It’s one thing to launch a new drug, and an entirely different thing to launch a new class of therapies,” Dendreon CEO Mitchell Gold said on a quarterly conference call today. “It’s a great responsibility we have.”
Today’s call was just the second time the company has reported on the market rollout of Provenge. The drug generated increasing sales each month—$5.2 million in July, $7.2 million in August, $7.8 million in September, and $9.5 million in October. The quarterly revenue of $20.2 million was a bit below the $24 million that Wall Street analysts had been expecting.
Dendreon spent a lot of time on today’s conference call walking through the demand and supply situation it is facing. About 1,000 prescriptions have been written by doctors, although not all of them have been fulfilled, because many patients have to go on waiting lists, said Dendreon’s chief operating officer, Hans Bishop. That means some patients won’t wait, and will end up seeking another form of treatment.
Dendreon’s three factories, when they are fully licensed and operating, are supposed to be able to supply the U.S. market with $1.25 billion to $2.5 billion worth of Provenge each year. Construction of the plants is “substantially complete,” and the company is working on typical activities to validate that it can produce the drug consistently at high quality, to satisfy regulators, Bishop said. Dendreon plans to seek FDA clearance to unleash the remaining 75 percent of its future capacity in New Jersey sometime this month, meaning that after a four-month regulatory review, that plant should be ready to boost output in March.
Still, that doesn’t mean Dendreon will instantly turn on the fire hose of more Provenge to clear out its waiting list of patients. The company actually plans to ramp up output in New Jersey in a “staged approach,” meaning it will gradually “bring it along in synch with an increase in demand,” Bishop said.
This is a tight-wire act for Dendreon to walk at the moment. Although more than 90 percent of targeted physicians were aware of the drug prior to its FDA approval, Dendreon hasn’t done much to market the drug yet, because it doesn’t want to disappoint people by putting them on a waiting list. Only 50 centers in the U.S. are currently able to fulfill orders for the product. The company will need to calibrate how and when new centers get trained to use the product, at the right moment when Dendreon is able to meet new demand.
Dendreon tried to manage expectations earlier this year, when it said it only would have enough capacity to meet demand from about 2,000 patients in the first 12 months. But the company carefully backed away from that today on the conference call, saying the forecast was used mainly to educate patients and physicians about the limited supplies. Dendreon now expects to deliver the drug to 2,000 patients by mid-2011, Gold said. Since the drug was approved by May 1, 2010, a strict interpretation of the original forecast would say Dendreon should hit the 2,000 patient number by that same date, May 1, 2011.
There wasn’t much new to say about the insurance reimbursement issue, other than that the company is preparing to make a case for Provenge at a public hearing on November 17 being convened by the Centers for Medicare and Medicaid Services. This panel will review the evidence to support the drug, which has prompted some investors to worry that the Medicare agency will put onerous reimbursement restrictions on doctors who prescribe this drug that costs $93,000 per patient. Dendreon made clear today it won’t back away an inch from the cost-benefit analysis it used to set the price. The price was based heavily on results from a pivotal trial of 512 men with terminal prostate cancer, which showed they lived a median time of about four months longer, with minimal side effects, than men who got a placebo.
“Over the last 15 years, only three therapies in metastatic cancer have been able to show a survival benefit of four months or more,” Bishop said.
Financially, there wasn’t a whole lot to say either, besides the sales forecast for 2011. Dendreon is in the midst of its budget process for 2011, said Greg Schiffman, the company’s chief financial officer. The company still plans to spend $460 million of its cash and investments this year. It expects to end the year with $250 million of cash and investments in the bank. He avoided one analyst’s question about whether the company expects to turn profitable in 2011, saying it’s too early to say until the budgeting process is complete.
Dendreon did have a few interesting bits of information to disclose beyond the all-important U.S. market introduction of Provenge. The company plans to discuss its strategy to introduce the drug outside the U.S. sometime late this year or in early 2011. This will require a lot of thought, about where it can set up manufacturing centers in Europe, how it can best appeal to European regulators, how big the opportunity may be there, and what kind of price it will be able to command from government payers.
Gold said the company is also thinking more broadly about its opportunities beyond Provenge. By the end of this year, the company plans to seek FDA clearance to start clinical trials of a second drug that uses Provenge-like technology. This treatment will be designed to stimulate the immune system against a market found on bladder cancer cells, known as HER2neu.
All this effort is taking more and more human resources than Dendreon has ever had before. The company, which had just 200 employees before its breakout success with the Provenge clinical trial in April 2009, has now expanded to more than 1,000 employees. That’s a lot of people being mobilized around a big new opportunity. While lots of people like to speculate about when Dendreon will sell out to a Big Pharma giant, the company is at least showing the outward signs of trying to capture this opportunity on its own.
“We are rapidly establishing a foundation for global growth and scientific innovation to improve the lives of patients with cancer,” Gold said.
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