“As we enter 2016, the fundamentals of Auryxia are solid, and we plan to build on that foundation to advance our launch in the U.S.,” said
FOURTH QUARTER 2015 AND RECENT BUSINESS HIGHLIGHTS
Auryxia (ferric citrate) Commercialization
Product Expansion Opportunities
Pivotal Phase 3 Trial Aimed at Increasing the Number of Adults Eligible for Treatment with Ferric Citrate
Potential Geographic Expansion
Fourth Quarter and Year Ended
“In the fourth quarter of 2015, we strengthened our financial position through a re-alignment of our cost structure and an infusion of capital, which we expect will take the Auryxia franchise to cash flow positive,” said
Total revenues for the quarter ended
Cost of goods sold for the quarter ended
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Net loss for the fourth quarter ended
2016 Financial Guidance
This section contains forward-looking guidance about the financial outlook for
Auryxia net U.S. product sales: Keryx expects full year 2016 Auryxia net U.S. product sales to be in the range of
Cash operating expenses: Keryx reiterated its cash operating expenses in 2016 will be in the range of
* Please refer to the section below titled “Use of Non-GAAP Financial Measures” for information about Keryx’s use of non-GAAP financial measures.
Conference Call Information
Keryx will host an investor conference call today,
About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was approved by the
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT), whereas these parameters remained relatively constant in patients treated with active control (Renvela® and/or Phoslo®). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia, visit www.Auryxia.com.
About Iron Deficiency Anemia in Chronic Kidney Disease
Iron deficiency anemia is the most common type of anemia and among the most common complication of chronic kidney disease. IDA is a condition where the body does not make enough healthy red blood cells and causes a considerable amount of weakness and fatigue, leading people to live a poor quality of life. IDA begins to develop in the early stages of CKD and tends to worsen as CKD progresses. Current oral medicines to treat IDA are not well tolerated. As a result, anemia in many patients remains untreated until hemoglobin levels severely decline. It is estimated that approximately 1.5 million people in the U.S. with stages 3-5 chronic kidney disease suffer from IDA, with the majority of these patients untreated.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA™ (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia™ (ferric citrate).
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/
Condensed Consolidated Statement of Operations
(In thousands, except share and per share amounts)
|Three Months Ended
|Net U.S. Auryxia product sales||$||4,770||$||—||$||10,141||$||—|
|Cost of goods sold||1,075||—||4,520||—|
|Research and development||7,990||5,815||36,694||51,502|
|Selling, general and administrative||21,563||34,050||81,410||70,057|
|Total Operating Expenses||31,236||40,206||124,748||122,054|
|Other income (expense), net||(12,308||)||52||(11,987||)||411|
|Loss Before Income Taxes||(37,761||)||(39,585||)||(123,055||)||(110,818||)|
|Net Loss Per Common Share
Basic and diluted net loss per common share
|Shares Used in Computing Net Loss Per Common Share|
|Basic and diluted||105,204,495||92,074,596||103,898,399||91,000,902|
Selected Consolidated Balance Sheet Data
|December 31, 2015||December 31, 2014*|
|Cash and cash equivalents||$||200,290||$||85,840|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||26,795||$||28,897|
|Convertible senior notes, net of discount||$||90,773||$||—|
Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia and our expected cash operating expenses, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: whether Auryxia will be successfully marketed in the U.S.; whether we can successfully obtain additional reimbursement coverage for Auryxia; whether we can adjust our operating expenses to projected levels while maintaining our current clinical and commercial activities; whether we will able to identify and negotiate acceptable terms with a commercialization partner in the E.U.; whether we or a partner can successfully launch Fexeric in the E.U.; whether Riona® will be successfully marketed in
Use of Non-GAAP Financial Measures
To supplement the financial measures presented in Keryx’ press release and related conference call or webcast in accordance with accounting principles generally accepted in
A “non-GAAP financial measure” refers to a numerical measure of the company’s historical or future financial performance, financial position, or cash flows that excludes (or includes) amounts that are included in (or excluded from) the most directly comparable measure calculated and presented in accordance with GAAP in the company’s financial statements. Keryx provides the non-GAAP measure listed above as additional information relating to Keryx’ expected operating results as a complement to results provided in accordance with GAAP. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for or superior to, the financial information presented in accordance with GAAP. There are significant limitations associated with the use of non-GAAP financial measures. Further, these measures may differ from the non-GAAP information, even where similarly titled, used by other companies and therefore should not be used to compare Keryx’ performance to that of other companies.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy SullivanVice President, Corporate Development and Public Affairs T: 617.466.3519 firstname.lastname@example.org Lora PikeSenior Director, Investor Relations T: 617.466.3511 email@example.com