Ardelyx Reports Fourth Quarter 2018 Financial Results and Recent Highlights
"Over the last year, we made significant progress towards developing our lead product candidate, tenapanor, and executing on our plan to provide patients with this first-ever, non-binder treatment option for the treatment of hyperphosphatemia for patients on dialysis," said
Key Accomplishments in 2018
- Initiated the PHREEDOM clinical trial, the company's second Phase 3 clinical trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease who are on dialysis. Topline results from this trial are expected in the fourth quarter of 2019.
- Initiated the Phase 3 AMPLIFY clinical trial, designed to evaluate expanded use of tenapanor as an adjunctive therapy to phosphate binders. Results from the AMPLIFY clinical trial are currently expected in the second half of 2019.
- Reported the unique mechanism of action for tenapanor to inhibit paracellular phosphate absorption in Science and Translational Medicine.
- Submitted and received acceptance of the filing of a New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C. The target action date under the Prescription Drug User Fee Act (PDUFA) is
September 12, 2019 . - Raised approximately
$100 million through equity and debt financing to support further development and commercial launch preparation for tenapanor for the treatment of hyperphosphatemia. - Received a
$5 million milestone payment inFebruary 2019 from the company's collaboration partner,Kyowa Hakko Kirin , for the initiation of a Phase 2 clinical study of tenapanor for hyperphosphatemia patients on dialysis inJapan .
Full Year 2018 Financial Results
- Cash Position: As of
December 31, 2018 ,Ardelyx had total capital resources including cash, cash equivalents and short-term investments of$168.1 million compared to total capital resources including cash, cash equivalents and short-term investments of$134.0 million as ofDecember 31, 2017 . - Revenue and Cost of Revenue: Total revenues were
$2.6 million in the year endedDecember 31, 2018 related to the company's ex-U.S. collaboration partnerships, and cost of revenues was$0.5 million related to payments due toAstraZeneca in accordance with the company's termination agreement entered into withAstraZeneca inJune 2015 . - R&D Expenses: Research and development expenses were
$69.4 million for the year endedDecember 31, 2018 , a decrease of$6.1 million , or 8%, compared to$75.5 million for the year endedDecember 31, 2017 . The decrease consisted of a$1.1 million decrease in external program costs primarily due to discontinuation of the RDX7675 program and the reduction of activities associated with the RDX8940 program that was partially offset by an increase in expense related to the company's tenapanor programs. There was a$5.0 million decrease in internal program costs primarily due to a decrease in personnel costs, including stock-based compensation costs as a result of a reduction in force during the third quarter of 2017, and a related decrease in research and development activities. - G&A Expenses: General and administrative expenses were
$23.7 million for the year endedDecember 31, 2018 , an increase of$0.5 million , or 2%, compared to$23.2 million for the year endedDecember 31, 2017 . The increase was primarily due to an increase in professional services and stock-based compensation expense, partially offset by a reduction in personnel costs due to reduction in force during the third quarter of 2017. - Net Loss: Net loss for the year ended
December 31, 2018 , was$91.3 million compared to a net loss of$64.3 million for the year endedDecember 31, 2017 .
Financial Guidance
About
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Ardelyx, Inc. |
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Consolidated Condensed Balance Sheets |
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(In thousands) |
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December 31, 2018 |
December 31, |
|||
(Unaudited) |
(1) |
|||
Assets |
||||
Cash and cash equivalents |
$ 78,768 |
$ 75,383 |
||
Short-term investments |
89,321 |
58,593 |
||
Accounts receivable |
85 |
10,796 |
||
Unbilled license revenue |
5,000 |
— |
||
Property and equipment, net |
5,611 |
8,032 |
||
Prepaid and other assets |
4,547 |
5,099 |
||
Total Assets |
$ 183,332 |
$ 157,903 |
||
Liabilities and stockholders' equity |
||||
Accounts payable and other current liabilities |
$ 16,728 |
$ 17,871 |
||
Uncharged license fees |
1,000 |
— |
||
Loan payable, long term |
49,209 |
— |
||
Other long-term liabilities |
582 |
720 |
||
Stockholders' equity |
115,813 |
139,312 |
||
Total liabilities and stockholders' equity |
$ 183,332 |
$ 157,903 |
||
(1) Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2017. |
Ardelyx, Inc. |
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Consolidated Statements of Operations |
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(In thousands, except share and per share amounts) |
|||||||||
Three Months Ended |
Twelve Months Ended |
||||||||
2018 |
2017 |
2018 |
2017 |
||||||
(Unaudited) |
(Unaudited) |
(Unaudited) |
(1) |
||||||
Revenue: |
|||||||||
Licensing revenue |
$ — |
$ 42,000 |
$ 2,320 |
$ 42,000 |
|||||
Other revenue |
85 |
— |
287 |
— |
|||||
Total revenues |
85 |
42,000 |
2,607 |
42,000 |
|||||
Cost of revenue |
— |
8,400 |
466 |
8,400 |
|||||
Gross Profit |
85 |
33,600 |
2,141 |
33,600 |
|||||
Operating expenses: |
|||||||||
Research and development |
$ 22,036 |
$ 17,159 |
$ 69,373 |
$ 75,484 |
|||||
General and administrative |
5,425 |
5,479 |
23,715 |
23,231 |
|||||
Total operating expenses |
27,461 |
22,638 |
93,088 |
98,715 |
|||||
(Loss) income from operations |
(27,376) |
10,962 |
(90,947) |
(65,115) |
|||||
Interest expense |
(1,438) |
— |
(3,534) |
— |
|||||
Other income |
950 |
331 |
3,187 |
1,955 |
|||||
Benefit from (provision for) income taxes |
2 |
(1,179) |
(4) |
(1,179) |
|||||
Net (loss) income |
$ (27,862) |
$ 10,114 |
$ (91,298) |
$ (64,339) |
|||||
Net (loss) income per common share, basic |
$ (0.45) |
$ 0.21 |
$ (1.62) |
$ (1.36) |
|||||
Shares used in computing net (loss) income per share, basic |
62,108,906 |
47,528,183 |
56,219,919 |
47,435,331 |
|||||
Net (loss) income per common share, diluted |
$ (0.45) |
$ 0.21 |
$ (1.62) |
$ (1.36) |
|||||
Shares used in computing net (loss) income per share, diluted |
62,108,906 |
48,724,123 |
56,219,919 |
47,435,331 |
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(1) Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2017. |
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SOURCE
Kimia Keshtbod, 510-745-1751, kkeshtbod@ardelyx.com, or Sylvia Wheeler, Wheelhouse Life Science Advisors, swheeler@wheelhouselsa.com, or Alex Santos, Wheelhouse Life Science Advisors, asantos@wheelhouselsa.com