– Supply interruption does not affect the safety profile of currently available Auryxia –
– Company withdraws its 2016 financial guidance –
– Company to host conference call today at
“We take our responsibility to patients and the treating community very seriously and recognize the impact this interruption of supply will cause for patients and their healthcare providers,” said
About the Supply Interruption
Keryx has determined that a supply interruption is going to occur due to a production-related issue in converting API to finished drug product at its contract manufacturer. This issue has resulted in variable production yields of finished drug product and, as a result, the company has exhausted its reserve of finished drug product. At this time, current inventories of Auryxia are not sufficient to ensure uninterrupted patient access to this medicine. The supply interruption does not affect the safety profile of currently available Auryxia. Keryx is working with its existing manufacturer to resolve the production-related issue and rebuild adequate supply. In addition, since approval of Auryxia in 2014, Keryx has been working to bring a secondary manufacturer online to supply finished drug product. The company recently filed for approval of this manufacturer with the
This supply interruption does not affect the supply of ferric citrate (marketed as Riona®) manufactured and sold by Keryx’s Japanese partner.
Second Quarter Business Update
Second Quarter Ended
“Although we are withdrawing our financial guidance for 2016, we believe we are well positioned financially to manage through this interruption in supply of Auryxia,” 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 quarter ended
Cash Operating Expenses (a non-GAAP measurement)*
Total operating expenses (excluding cost of goods sold and license expenses) for the second quarter ended
2016 Financial Guidance
As a result of the supply interruption, Keryx is withdrawing its 2016 financial guidance.
* 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,
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). 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 and the U.S. full prescribing information, visit www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA®
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.
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/
|Keryx Biopharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
|Six Months Ended
|Net U.S. Auryxia product sales||$||8,279||$||1,758||$||13,895||$||2,180|
|Cost of goods sold||5,099||304||6,170||380|
|Research and development||7,029||7,963||14,645||17,554|
|Selling, general and administrative||20,188||20,762||40,997||39,642|
|Total Operating Expenses||32,921||29,482||63,143||58,481|
Other Income (expense):
|Other income (expense), net||(20,998||)||114||(38,545||)||221|
|Loss Before Income Taxes||(44,631||)||(26,854||)||(85,575||)||(54,571||)|
|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||105,842,030||104,564,971||105,745,800||102,570,312|
|Selected Consolidated Balance Sheet Data|
|June 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||155,796||$||200,290|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||19,788||$||26,795|
|Convertible senior notes, net of discount||$||125,000||$||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 as well as the expected impact of the supply interruption of Auryxia and the expected timing of when we will have a sufficient supply of Auryxia to make it available to patients again following the supply interruption, 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: our ability to quickly and successfully identify and resolve the production-related issue; our ability to quickly and successfully identify and engage secondary suppliers of finished drug product; our ability to receive
Use of Non-GAAP Financial Measures
To supplement the financial measures presented in Keryx’s 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’s 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’s 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