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Ardelyx Inc. (ARDX) to Report Q4 Earnings: What's in Store?
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We expect investors to focus on sales numbers of Ardelyx Inc.’s (ARDX - Free Report) only marketed product, Ibsrela (tenapanor), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults when it reports fourth-quarter 2022 results later this February.
Shares of Ardelyx have surged 315.8% in the past year against the industry’s decline of 14.7%.
Image Source: Zacks Investment Research
ARDX’s earnings surpassed expectations in one of the trailing four quarters, was at par with expectation on one occasion and missed twice. In the last reported quarter, Ardelyx reported a positive earnings surprise of 17.65%.
Let us see how things have shaped up for the quarter to be reported.
Factors to Consider
Currently, Ardelyx has only one marketed product in its portfolio, Ibsrela (tenapanor), which is a first-in-class NHE3 inhibitor, for the treatment of IBS-C in adults, which was approved by the FDA in the United States in April 2022.
In the last reported quarter, Ardelyx’s product revenues from the sale of Ardelyx amounted to $4.9 million, signifying a sequential growth in revenues of 206.25%. We expect the product to have generated higher sales in the fourth quarter.
Apart from Ibsrela, investors can expect an update from the company’s other pipeline candidate, Xphoza (tenapanor) which has been developed for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The company submitted a new drug application (NDA) to the FDA for Xphozah e, back in June 2020. However, in July 2021, the FDA issued a complete response letter (CRL) to Ardelyx for the NDA, Per the FDA, the data submitted by Ardelyx along with the NDA for approval was not adequate and did not address clinical significance. The FDA said that the company needs to conduct further studies to demonstrate the clear efficacy of the drug with statistical significance.
Ardelyx disputed the FDA’s CRL and appealed to the Office of New Drugs (OND), Center for Drug Evaluation and Research of the FDA in July 2021 for Xphozah with further data submission from the phase III clinical study for Xphozah. In April 2022, Ardelyx reported the FDA’s plan, going forward with the Xphozah NDA. Per the OND, the NDA for Xphozah was directed to the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for review. In November 2022, The CRDAC voted in favor of Xphozah, nine to four, stating that the benefits of treatment with Xphozah outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy. The committee further voted ten to one, with one abstention, that the benefits of treatment with Xphozah in combination with phosphate binder treatment outweigh its risks.
Post the CRDAC’s positive recommendation, the FDA granted Ardelyx’s appeal to the CRL in December 2022. Per the FDA, Ardelyx is instructed to meet with the Division of Cardiology and Nephrology to determine the specific information that will form the basis for the resubmission of the NDA for Xphozah.
Ardelyx expects to complete the resubmission of the NDA for Xphozah in the first half of 2023.
Earnings Whisper
Our proven model does not conclusively predict an earnings beat for Ardelyx this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy), or 3 (Hold) increases the odds of an earnings beat. Unfortunately, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Ardelyx has an Earnings ESP of 0.00% as the Zacks Consensus Estimate and the Most Accurate Estimate both stand at a cent.
Here are some stocks in the same industry that have the right combination of elements to beat on earnings this time around:
Assertio (ASRT - Free Report) has an Earnings ESP of +2.38% and a Zacks Rank #3.
Assertio’s stock has risen 113.9% in the past year. Assertio beat earnings estimates in three of the last four quarters while missing the mark on one occasion. ASRT has an earnings surprise of 54.96% on average.
FibroGen (FGEN - Free Report) has an Earnings ESP of +1.16% and a Zacks Rank #3.
FibroGen’s stock has risen 57.1% in the past year. FibroGen beat earnings estimates in two of the last four quarters while missing the mark on two occasions. FGEN has a four-quarter negative earnings surprise of 23.81% on average.
EQRx has an Earnings ESP of +5.26% and a Zacks Rank #2.
EQRx’s stock has plunged 33.2% in the past year. EQRx beat earnings estimates in all the last three reported quarters. EQRX has an earnings surprise of 22.10% on average.
Image: Bigstock
Ardelyx Inc. (ARDX) to Report Q4 Earnings: What's in Store?
We expect investors to focus on sales numbers of Ardelyx Inc.’s (ARDX - Free Report) only marketed product, Ibsrela (tenapanor), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults when it reports fourth-quarter 2022 results later this February.
Shares of Ardelyx have surged 315.8% in the past year against the industry’s decline of 14.7%.
Image Source: Zacks Investment Research
ARDX’s earnings surpassed expectations in one of the trailing four quarters, was at par with expectation on one occasion and missed twice. In the last reported quarter, Ardelyx reported a positive earnings surprise of 17.65%.
Let us see how things have shaped up for the quarter to be reported.
Factors to Consider
Currently, Ardelyx has only one marketed product in its portfolio, Ibsrela (tenapanor), which is a first-in-class NHE3 inhibitor, for the treatment of IBS-C in adults, which was approved by the FDA in the United States in April 2022.
In the last reported quarter, Ardelyx’s product revenues from the sale of Ardelyx amounted to $4.9 million, signifying a sequential growth in revenues of 206.25%. We expect the product to have generated higher sales in the fourth quarter.
Apart from Ibsrela, investors can expect an update from the company’s other pipeline candidate, Xphoza (tenapanor) which has been developed for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The company submitted a new drug application (NDA) to the FDA for Xphozah e, back in June 2020. However, in July 2021, the FDA issued a complete response letter (CRL) to Ardelyx for the NDA, Per the FDA, the data submitted by Ardelyx along with the NDA for approval was not adequate and did not address clinical significance. The FDA said that the company needs to conduct further studies to demonstrate the clear efficacy of the drug with statistical significance.
Ardelyx disputed the FDA’s CRL and appealed to the Office of New Drugs (OND), Center for Drug Evaluation and Research of the FDA in July 2021 for Xphozah with further data submission from the phase III clinical study for Xphozah. In April 2022, Ardelyx reported the FDA’s plan, going forward with the Xphozah NDA. Per the OND, the NDA for Xphozah was directed to the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for review. In November 2022, The CRDAC voted in favor of Xphozah, nine to four, stating that the benefits of treatment with Xphozah outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy. The committee further voted ten to one, with one abstention, that the benefits of treatment with Xphozah in combination with phosphate binder treatment outweigh its risks.
Post the CRDAC’s positive recommendation, the FDA granted Ardelyx’s appeal to the CRL in December 2022. Per the FDA, Ardelyx is instructed to meet with the Division of Cardiology and Nephrology to determine the specific information that will form the basis for the resubmission of the NDA for Xphozah.
Ardelyx expects to complete the resubmission of the NDA for Xphozah in the first half of 2023.
Earnings Whisper
Our proven model does not conclusively predict an earnings beat for Ardelyx this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy), or 3 (Hold) increases the odds of an earnings beat. Unfortunately, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Ardelyx has an Earnings ESP of 0.00% as the Zacks Consensus Estimate and the Most Accurate Estimate both stand at a cent.
Ardelyx, Inc. Price, Consensus and EPS Surprise
Ardelyx, Inc. price-consensus-eps-surprise-chart | Ardelyx, Inc. Quote
Zacks Rank: Ardelyx currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here
Stocks to Consider
Here are some stocks in the same industry that have the right combination of elements to beat on earnings this time around:
Assertio (ASRT - Free Report) has an Earnings ESP of +2.38% and a Zacks Rank #3.
Assertio’s stock has risen 113.9% in the past year. Assertio beat earnings estimates in three of the last four quarters while missing the mark on one occasion. ASRT has an earnings surprise of 54.96% on average.
FibroGen (FGEN - Free Report) has an Earnings ESP of +1.16% and a Zacks Rank #3.
FibroGen’s stock has risen 57.1% in the past year. FibroGen beat earnings estimates in two of the last four quarters while missing the mark on two occasions. FGEN has a four-quarter negative earnings surprise of 23.81% on average.
EQRx has an Earnings ESP of +5.26% and a Zacks Rank #2.
EQRx’s stock has plunged 33.2% in the past year. EQRx beat earnings estimates in all the last three reported quarters. EQRX has an earnings surprise of 22.10% on average.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.