Keryx Biopharmaceuticals (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for people with renal disease, today announced its financial results for the second quarter ended June 30, 2015.
“We are making progress on several important milestones across our business, including securing broad reimbursement for Auryxia™ (ferric citrate) that today enables unrestricted access for approximately 65 percent of phosphate binder patients,” said Greg Madison, chief executive officer of Keryx. “Our second quarter results show that Auryxia’s traction is increasing as we gain reimbursement access. Given that we now have access to the majority of patients and the amount of time required with the dialysis care team to pull through prescriptions, we have decided to add approximately 30 sales representatives to our field sales team. The increase from 60 to approximately 90 representatives, which we expect to complete in the fourth quarter, will allow us to increase our reach and frequency of contact with physicians and the dialysis care team.”
Madison continued, “We continue to make progress on two growth opportunities, with the recent CHMP positive opinion in the E.U. for Fexeric® and completion of enrollment in the ongoing Phase 3 label expansion study for Auryxia. These advancements bring us closer to delivering on our goal of building a market leading renal business.”
Auryxia U.S. Commercialization
- Net U.S. Auryxia product sales for the second quarter were approximately $1.8 million, based on approximately 3,700 Auryxia prescriptions, as reported to the company by IMS Health and specialty pharmacies that do not report data to IMS, including DaVita Rx and Fresenius Rx.
- Unrestricted access for Auryxia increased to 65 percent across Medicare Part D and commercial insurance providers, with the addition of Auryxia on the formularies of two national Part D insurance providers that began processing claims in the third quarter of 2015.
- Keryx’s sales representatives have reached more than 75 percent of the 5,000 prescriber targets; approximately 1,000 target prescribers have written a prescription for Auryxia.
- Keryx successfully introduced samples into the market in the second quarter, with approximately 6,000 starter kits shipped to approximately 1,300 target prescribers – the majority of whom had not previously prescribed Auryxia.
Product Expansion Opportunities
- Keryx recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Fexeric (ferric citrate coordination complex) recommending approval for the control of serum phosphorus levels, or hyperphosphatemia, in adults with non-dialysis and dialysis-dependent chronic kidney disease (CKD). The European Commission is now reviewing the opinion and the company expects a decision on regulatory approval in approximately two to three months from the CHMP opinion. Keryx expects to finalize commercial plans for the EU by the end of 2015.
- Keryx announced today that enrollment is complete in the Phase 3 study evaluating Auryxia in people with stages 3-5 non-dialysis dependent CKD and iron deficiency anemia, who have previously not responded or were intolerant to oral iron therapy. The study is designed to expand the indication of Auryxia in the U.S. to include the treatment of iron deficiency anemia. The company expects to complete the study in January 2016 and release the results in the second quarter of 2016. If this study is successful, Keryx intends to submit for approval with the FDA in the third quarter of 2016.
SECOND QUARTER FINANCIAL RESULTS
At June 30, 2015, the company had cash and cash equivalents of $131.3 million.
Net loss for the second quarter ended June 30, 2015 was $26.9 million, or $0.26 per share, compared to a net loss of $22.4 million, or $0.24 per share, for the comparable quarter in 2014, representing an increase in net loss of $4.5 million.
Total revenues for the second quarter ended June 30, 2015 were approximately $2.5 million. There was no revenue for the second quarter ended June 30, 2014. Total revenues for the second quarter of 2015 represent the following:
- Net U.S. Auryxia product revenue of $1.8 million, and
- License revenue of $756,000 associated with royalties received on ferric citrate sales in Japanrelated to their net sales during the first quarter of 2015.
Research and development expenses for the second quarter ended June 30, 2015 were $8.0 millioncompared to $10.3 million for the three months ended June 30, 2014. The decrease was due to a $1.3 million decrease in regulatory and clinical study expenses related to Auryxia and a $3.7 million decrease in expenses related to the manufacturing of Auryxia, which were expensed in the comparable period in 2014 and primarily capitalized as inventory following the approval of Auryxia in September 2014. The three months ended June 30, 2015 included $2.1 million of expenses for medical affairs activities, as the medical affairs group will increasingly be supporting additional research and development of Auryxia in the post-approval setting and, therefore, the associated costs are included in research and development expenses as of January 2015.
Selling, general and administrative expenses for the second quarter ended June 30, 2015, increased by$8.5 million to $20.8 million, as compared to $12.3 million for the three months ended June 30, 2014. The increase was primarily related to an $8.8 million increase in commercial activities and associated personnel costs related to the commercialization of Auryxia, which included a $0.9 millionincrease in associated stock-based compensation expense related to the recording of the fair value of equity awards granted. (Original Source)
Shares of Keryx Biopharmaceuticals closed yesterday at $7.34. KERX has a 1-year high of $18.48 and a 1-year low of $7.29. The stock’s 50-day moving average is $9.34 and its 200-day moving average is $11.13.
On the ratings front, Keryx Biopharmaceuticals has been the subject of a number of recent research reports. In a report issued on July 24, Maxim Group analyst Jason Kolbert reiterated a Buy rating on KERX, with a price target of $17, which represents a potential upside of 131.6% from where the stock is currently trading. Separately, on July 23, Cowen’s Boris Peaker downgraded the stock to Hold and has a price target of $18.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Boris Peaker have a total average return of -6.4% and 32.4% respectively. Kolbert has a success rate of 33.3% and is ranked #3681 out of 3724 analysts, while Peaker has a success rate of 56.8% and is ranked #48.
Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $20.80 which is 183.4% above where the stock closed yesterday.
Keryx Biopharmaceuticals Inc is a biopharmaceutical company focused on therapies for patients with renal disease. Its first product is the AuryxiaTM (ferric citrate), an oral, absorbable iron-based compound.