Keryx Biopharmaceuticals (KERX) has been an awful stock to hold this year. Coming into this morning's earnings release, shares of the renal disease-focused drug maker were down a gut-wrenching 68% year-to-date. Understandably, its investors were likely holding their collective breath as the company reported its quarterly results.
Thankfully, it appears that the company has finally provided investors with reasons to be hopeful about its future, as its quarterly earnings results today have investors bidding up shares by more than 12% today.
Total sales for the quarter came in at $4.2 million, which was well ahead of the $3.81 that analysts were expecting. Results were driven by $3.2 million is U.S. sales of Auryxia, the company's only approved drug, while royalty payments received from its Japanese partnership with Torii Pharmaceutical, a division of Japan Tobacco (JAPAF 4.32%), added another $1 million to the total.
While the top-line beat was certainly good news, revenue didn't trickle down to the bottom line as well as investors were hoping for, as net loss for the quarter came in at $30.7 million, or $0.29 per share -- worse than the $0.25 that analysts were expecting.
Auryxia finally gaining traction?
All eyes were on script volume for Auryxia this quarter, as it managed to increase a very healthy 45% over last quarter's results, which certainly lends credence to management's previous claims that reimbursement was a major barrier to a fast adoption. Now that the majority of patients can access Auryxia affordably, it appears that sales continued to grow nicely.
Better still, the company provided its investors with data that suggests that adherence to its therapy is very strong, with 79% of patients sticking with it after getting started. Of the patients that discontinued therapy, the majority appear to have done so because of cost concerns, which could certainly continue to lessen over time as reimbursement for the therapy continues to grow.
Source: Spherix Global Insights, August 2015 market research
Keryx's pulling out all the stops in order to ensure that its growth rate continues. It previously announced that it is increasing its sales force by 50%, and the majority of those new positions are expecting to be up and running by year-end.
In addition, the company will be displaying three posters at upcoming American Society of Nephrology meeting in November, which the company is hoping will help to convince reluctant physicians to give Auryxia a try.
Label expansion
Looking a bit further down the road, the company completed enrollment in July for its Phase 3 program testing Auryxia's use in patients who are in the pre-dialysis phase. The company expects to have top-line safety data available in the second quarter of 2016. If all goes well it intends to submit for approval with the FDA in the third quarter of next year, which could go a long way toward expanding the addressable patient population for the drug.
European opportunity
Keryx was able to grab a regulatory nod for Auryxia across the pond last month, where it is will be sold under the brand name Fexeric. The company has made the decision to use a partner instead of try and sell its drug directly. While a partner has not yet been announced, the opportunity in Europe looks huge, as Fexeric already has labelling that includes patients who are in both dialysis and pre-dialysis, which is a broader indication than Auryxia currently has in the States.
In addition, the European Commission has provided Fexeric with the coveted New Active Substance designation, which gives it 10 years of marketing exclusivity.
A cash infusion
On the financial front, the company appears to be well capitalized after raising an additional $125 million in a convertible notes deal with famed investor Seth Klarman's Baupost Group. The market certainly reacted favorably to the news, as the cash infusion is certainly a major vote of confidence -- the Baupost Group was already the company's largest shareholder.
In addition, the company has begun to implement cost cutting efforts in an attempt to reach break-even as quickly as possible. With $227 million in cash on its books, if sales continue to grow briskly then it appears that is has enough capital to get there.
The shorts go running
Short sellers, or investors who profit when a stock falls, have been piling against Keryx since the start of the year, as Auryxia's decline gave bears plenty of reasons to doubt the drug. Total shares sold short have plummeted since the start of October.
What now?
Of course, only time will tell if today's reported beat was the start of a long-term trend or simply a one time anomaly. If indeed Auryxia's woes are finally behind it, then Keryx shareholders could be primed to have a very prosperous 2016.
