Ardelyx, Inc. (ARDX) 10-K Annual Report March 2019

-- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2018.

“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 Mike Raab, president and chief executive officer of Ardelyx. “We enter 2019 well-positioned with two years of cash on hand to deliver on our strategic goals to report results from two Phase 3 clinical trials during the second half of the year and to prepare for commercialization of our novel therapy.”

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 in February 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 in Japan.

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 of December 31, 2017.

Revenue and Cost of Revenue: Total revenues were $2.6 million in the year ended December 31, 2018 related to the company’s ex-U.S. collaboration partnerships, and cost of revenues was $0.5 million related to payments due to AstraZeneca in accordance with the company’s termination agreement entered into with AstraZeneca in June 2015.

R&D Expenses: Research and development expenses were $69.4 million for the year ended December 31, 2018, a decrease of $6.1 million, or 8%, compared to $75.5 million for the year ended December 31, 2017. The decrease consisted of a $1.1 million decrease in external program costs primarily due to

The following information was filed by Ardelyx, Inc. (ARDX) on Wednesday, March 6, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Ardelyx, Inc.'s 10-K Annual Report:

Financial - Expense Highlight
The net loss of $91.3 million was adjusted for (i) non-cash charges of $2.4 million related to depreciation, amortization, non-cash interest expense and change in derivative liabilities and $9.2 million for stock-based compensation, (ii) a decrease of $10.7 million in accounts receivable related to the Fosun Pharma license upfront fee received, (iii) a $0.5 million decrease in prepaid expenses primarily advances to vendors for clinical development and manufacturing, and (iv) a decrease in accounts payable and accrued liabilities of $1.8 million primarily due to expenses incurred for the clinical manufacturing, process development, and clinical development activities for tenapanor.

Financial - Expense Highlight
The net loss of $112.4 million was adjusted for (i) an increase of accounts payable and accrued liabilities of $11.2 million primarily due to expenses incurred for the clinical manufacturing, process development, and clinical development activities for tenapanor, RDX7675 and RDX8940, (ii) non-cash charges of $1.8 million for depreciation and amortization and $5.3 million for stock-based compensation and (iii) pre-payments of $1.6 million to vendors for clinical development and manufacturing activities.
Revenue - Product Highlight
As a result of the adoption of the new standard, on January 1, 2018, we recorded the following: (i) an increase in current assets of $5.0 million representing a receivable related to the first milestone under our KHK license agreement, which was achieved by KHK in February 2019, (ii) an increase in current liabilities of $1.0 million representing a payable related to the corresponding payment to AstraZeneca in accordance with our termination agreement with AstraZeneca and (iii) a related decrease in its accumulated deficit of approximately $4.0 million as the new standard permits revenue from milestones that possess certain criteria to be recognized earlier as the new standard contains different recognition criteria related to milestones than under the previous standard, Revenue Recognition, Multiple-Element Arrangements - Licensing revenues, ASC 605.
Revenue - Product Highlight
In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under each of our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
Financial - Expense Highlight
The decrease in our external program costs of $23.8 million was primarily due to a decrease of $22.3 million in expenses incurred for clinical development activities related to the completion of our T3MPO Phase 3 clinical program for tenapanor, our first Phase 3 clinical trial evaluating tenapanor for the treatment of hyperphosphatemia patients with ESRD on dialysis and a decrease in manufacturing development activities related to tenapanor.
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The net loss of $64.3...Read more
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Royalties: For arrangements that include...Read more
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________________________ * not meaningful Licensing...Read more
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Ardelyx, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: ARDX
CIK: 1437402
Form Type: 10-K Annual Report
Accession Number: 0001558370-19-001583
Submitted to the SEC: Wed Mar 06 2019 11:12:09 AM EST
Accepted by the SEC: Wed Mar 06 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations