Ardelyx, Inc. (ARDX) 10-Q Quarterly Report May 2022

- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today provided a business update and reported financial results for the first quarter ended March 31, 2022.

“Ardelyx is off to a great start in 2022, with the commercial launch of IBSRELA®, our first-in-class, novel therapy for the treatment of IBS-C in adults,” said Mike Raab, president and chief executive officer of Ardelyx. “Initial channel stocking began in late March, the sales force is mobilized across the country, and early response to the product as a new treatment option has been positive. In parallel, we continue to persist in our pursuit of FDA approval for XPHOZAH®, our first-in-class, phosphate absorption inhibitor, and received notification from the FDA that an advisory committee meeting will be convened to get further input from experts, augmented with clinicians familiar with the clinical management of hyperphosphatemia.”

Recent Business Highlights

•On April 4, 2022, the company announced the launch of IBSRELA (tenapanor), the first and only NHE3 inhibitor for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is the first FDA-approved product for Ardelyx. Commercial efforts are focused on the 9,000 HCPs who account for 50% of the prescriptions of IBS-C indicated products, with broad-based distribution, a targeted specialty sales force, and omnichannel tactics. Marketing messages center on the multifactorial pathophysiology of IBS-C, and the role novel mechanism IBSRELA can play to address important medical unmet needs.

•The company presented multiple presentations at the National Kidney Foundation 2022 Spring Clinical Meetings, in Boston, MA on April 6-10, 2022, covering additional positive clinical observations of XPHOZAH an investigational, first-in-class, phosphate absorption inhibitor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The following information was filed by Ardelyx, Inc. (ARDX) on Thursday, May 5, 2022 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-Q Quarterly 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-Q Quarterly Report:

Financial - Expense Highlight
We believe our cost of goods sold for the three months ended March 31, 2022 would have been $9 thousand higher, if we had not previously expensed certain material and production costs with respect to the units sold.

Revenue - Product Highlight
Pursuant to the 2021 Open Market Sales Agreement, Jefferies, as our sales agent, receives a commission of up to 3% of the gross sales price for shares of common stock sold under the 2021 Open Market Sales Agreement.
Revenue - Product Highlight
Under the terms of the agreement with KKC, we received a $30.0 million upfront payment from KKC, and we may be entitled to receive up to $55.0 million in total development milestones, of which $10.0 million has been received and recognized as revenue as of March 31, 2022, and approximately 8.5 billion for commercialization milestones, or approximately $69.7 million at the currency exchange rate on March 31, 2022, as well as royalties on net sales throughout the term of the agreement.
Financial - Cash Flow Highlight
Cash Flows from Investing Activities Net cash provided by investing activities decreased by $0.2 million due to the timing of our investment maturities and purchases, as well as $0.8 million proceeds from sale of laboratory equipment and supplies during the three months ended March 31, 2022.
Financial - Expense Highlight
We recognize these expenses as cost of revenue when we recognize the corresponding revenue that gives rise to payments due to AstraZeneca.
Revenue - Product
Comparison of the three months...Read more
Financial - Expense
27 Table of Contents Research...Read more
Financial - Expense
Selling, General and Administrative The...Read more
Financial - Expense
The gain was partially offset...Read more
Financial - Cash Flow
Cash Flows from Financing Activities...Read more
Financial - Income
Other Income, net Below is...Read more
Financial - Cash Flow
- Risk Factors- Risks Related...Read more
Other - Other
Under the terms of the...Read more
Other - Other
Recent Accounting Pronouncements A summary...Read more
Financial - Cash Flow
30 Table of Contents CASH...Read more
Other - Other
According to the CRL, while...Read more
Financial - Shares
During the three months ended...Read more
Financial - Shares
During the three months ended...Read more
Other - Other
Please see the risk factors...Read more
Revenue - Product
Partially offsetting these decreases was...Read more
Revenue - Product
Revenue from product sales is...Read more
Revenue - Product
Variable consideration is included in...Read more
Financial - Expense
The decrease in our employee-related...Read more
Other - Other
The OND noted that additional...Read more
Revenue - Product
Amounts for estimated chargebacks are...Read more
Revenue - Product
Reserves for Variable Consideration Revenues...Read more
Legal - Other
These estimates are based on...Read more
Other - Other
We have undertaken measures to...Read more
Revenue - Product
The royalty rate will be...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

Exhibit 10.1: Material Contract

Exhibit 10.2: Material Contract

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-Q Quarterly Report
Accession Number: 0001628280-22-012630
Submitted to the SEC: Thu May 05 2022 4:06:34 PM EST
Accepted by the SEC: Thu May 05 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations