When is a commercial drug launch not really a commercial drug launch?
Monday night, Rockwell admitted to investors it managed to "sell" the kidney dialysis product Triferic for the last four months of 2015 without actually selling any of the product.
Rockwell shares plunged 28% to $6.95 in after-hours trading. The stock has dropped 61% below its all-time high reached last July.
The Triferic commercial launch started in September 2015, yet fourth-quarter and 2015 sales of Triferic were "immaterial," said Rockwell CFO Tom Klema, speaking to investors on a conference call.
Klema said nothing at all about how Triferic was performing in the first two months of 2016, either, which doesn't exactly inspire confidence in first-quarter sales.
Actual Triferic sales in 2015 were $200,000, reported in Rockwell's 10-K filed later Monday night. To put that number in perspective, Triferic's first quarter of commercial sales is lower than comparable drug-launch quarters reported by Keryx Pharmaceuticals (KERX) - Get Report and Mannkind (MNKD) - Get Report -- two companies infamous for astoundingly bad drug marketing.
Rockwell isn't delivering Triferic sales, but it is offering excuses and lots of hand waving.
"We had an exceptional year in 2015," said CEO Robert Chioni.
Except for the last four months of 2015, during which Rockwell managed to not sell Triferic.
"We've been making solid progress and we continue to execute on the various tasks required for any new product to succeed," Chioni added.
Except the task where customers pay for Triferic.
Rockwell's failure to launch doesn't surprise anyone who has followed the company's development path over the past two years. Triferic was pitched as a convenient and cost-saving iron replacement therapy for kidney dialysis patients. The FDA approved Triferic over the objections of its own medical reviewers, who called Rockwell's clinical trials "contrived" and concluded that any benefit seen with Triferic was clouded by an 80% patient drop-out rate.
On Rockwell's Monday night call, CEO Chioni blamed Triferic's poor sales on the product's packaging and suboptimal Medicare reimbursement. He promised fixes but offered no timelines.
The Rockwell conference call lasted just 28 minutes. It ended abruptly after Stifel analyst Annabel Samimy asked Chioni to explain why the Triferic commercial launch was such a disaster. She was the only analyst to ask a question. After the call, Samimy downgraded Rockwell to hold from buy.
It's hard to imagine, but Triferic is actually performing better than Rockwell's other approved drug, Calcitriol, a generic vitamin D injection also aimed at the dialysis market.
Rockwell secured Calcitriol's U.S. approval in June 2014, but the product still isn't launched commercially.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.