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Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) reported adjusted earnings of 27 cents per share in fourth-quarter 2022, missing both the Zacks Consensus Estimate and our estimate of 28 cents and 29 cents per share, respectively. The reported earnings were in line with the year-ago quarter figure.
Total revenues of $107.2 million also missed the Zacks Consensus Estimate and our estimate, which stood at $108 million. Revenues were down 8.5% year over year.
Shares of Ironwood have risen 7.0% this year against the industry’s fall of 11.0%.
Image Source: Zacks Investment Research
Quarter in Detail
As reported by partner AbbVie (ABBV - Free Report) , Ironwood’s sole marketed product — Linzess (linaclotide) — generated net sales of almost $260.3 million in the United States, down 7% year over year. Ironwood and AbbVie equally share Linzess’ brand collaboration profits or losses.
Ironwood's share of net profits from the sales of Linzess in the United States (included in collaborative revenues) was $104.8 million in the fourth quarter, down 8% year over year.
The performance can be attributed to a massive acceleration in new prescription volume. In the reported quarter, the new prescription share reached 45% and new-to-brand volume increased 9% year-over-year.
The company recorded $2.4 million in royalties and other revenues compared with $3.4 million in the year-ago quarter.
Ironwood also has agreements with two partners — Astellas Pharma and AstraZeneca (AZN - Free Report) — related to the development and commercialization of Linzess in Japan and China, respectively. Both Astellas and AstraZeneca have exclusive rights to develop and market the drug in their respective territories. Astellas and AstraZeneca are liable to pay royalties to Ironwood on net Linzess sales made in their respective territories.
Besides Japan and China, AbbVie holds exclusive global rights to develop and market Linzess. AbbVie markets Linzess in Europe and Canada under the brand name Constella. Ironwood is eligible to receive royalties on net product sales of the drug from AbbVie.
Selling, general and administrative expenses were down 1.0% year over year to $28.4 million during the fourth quarter. Research & development expenses declined 67.2% year over year to $10.4 million.
Full-Year Results
Ironwood reported revenues of $410.6 billion, down 0.8% year over year. Sales were primarily driven by its share of the net profits of $398.8 million from the sales of Linzess in the United States. The drug’s total sales were $1.0 billion for the full year.
The company’s adjusted earnings for 2022 were 96 cents per share, down 17.2% from the year-ago period.
2023 Guidance
Ironwood maintained its previously issued guidance for 2023. The company expects its total revenues to be between $420 million and $435 million. It expects U.S. sales of Linzess to grow in the range of 3% and 5%.
The company expects adjusted EBITDA to be more than $250 million for the year.
Pipeline Updates
Ironwood is also focused on the label expansion of Linzess, which will help drive its sales following successful development and potential approval.
Earlier this week, the company, along with partner AbbVie, announced that the FDA accepted and granted priority review to a supplemental new drug application (sNDA), seeking expanded use of Linzess for children and adolescents with functional constipation (“FC”). A final decision on the sNDA is expected in June 2023. FC currently has no FDA-approved therapies for children.
Other than Linzess, Ironwood is also evaluating two other pipeline candidates — IW-3300 and CNP-104 — for treating visceral pain conditions and primary biliary cholangitis, respectively. Management intends to start dosing study participants in the ongoing phase II proof-of-concept study evaluating IW-3300 in interstitial cystitis/bladder pain syndrome (“IC/BPS”) in early-2023.
Aeterna Zentaris loss per share estimates for 2023 have narrowed from $3.68 to $3.30 in the past 30 days. AEZS’s stock has plunged 62.6% in the past year.
Earnings of Aeterna Zentaris missed estimates in two of the last four quarters and met the mark on the other two occasions. On average, AEZS witnessed a trailing four-quarter positive earnings surprise of 7.72%, on average. In the last reported quarter, Aeterna Zentaris’ earnings missed estimates by 2.94%.
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Ironwood (IRWD) Q4 Earnings Miss, Linzess Volume Increases
Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) reported adjusted earnings of 27 cents per share in fourth-quarter 2022, missing both the Zacks Consensus Estimate and our estimate of 28 cents and 29 cents per share, respectively. The reported earnings were in line with the year-ago quarter figure.
Total revenues of $107.2 million also missed the Zacks Consensus Estimate and our estimate, which stood at $108 million. Revenues were down 8.5% year over year.
Shares of Ironwood have risen 7.0% this year against the industry’s fall of 11.0%.
Image Source: Zacks Investment Research
Quarter in Detail
As reported by partner AbbVie (ABBV - Free Report) , Ironwood’s sole marketed product — Linzess (linaclotide) — generated net sales of almost $260.3 million in the United States, down 7% year over year. Ironwood and AbbVie equally share Linzess’ brand collaboration profits or losses.
Ironwood's share of net profits from the sales of Linzess in the United States (included in collaborative revenues) was $104.8 million in the fourth quarter, down 8% year over year.
The performance can be attributed to a massive acceleration in new prescription volume. In the reported quarter, the new prescription share reached 45% and new-to-brand volume increased 9% year-over-year.
The company recorded $2.4 million in royalties and other revenues compared with $3.4 million in the year-ago quarter.
Ironwood also has agreements with two partners — Astellas Pharma and AstraZeneca (AZN - Free Report) — related to the development and commercialization of Linzess in Japan and China, respectively. Both Astellas and AstraZeneca have exclusive rights to develop and market the drug in their respective territories. Astellas and AstraZeneca are liable to pay royalties to Ironwood on net Linzess sales made in their respective territories.
Besides Japan and China, AbbVie holds exclusive global rights to develop and market Linzess. AbbVie markets Linzess in Europe and Canada under the brand name Constella. Ironwood is eligible to receive royalties on net product sales of the drug from AbbVie.
Selling, general and administrative expenses were down 1.0% year over year to $28.4 million during the fourth quarter. Research & development expenses declined 67.2% year over year to $10.4 million.
Full-Year Results
Ironwood reported revenues of $410.6 billion, down 0.8% year over year. Sales were primarily driven by its share of the net profits of $398.8 million from the sales of Linzess in the United States. The drug’s total sales were $1.0 billion for the full year.
The company’s adjusted earnings for 2022 were 96 cents per share, down 17.2% from the year-ago period.
2023 Guidance
Ironwood maintained its previously issued guidance for 2023. The company expects its total revenues to be between $420 million and $435 million. It expects U.S. sales of Linzess to grow in the range of 3% and 5%.
The company expects adjusted EBITDA to be more than $250 million for the year.
Pipeline Updates
Ironwood is also focused on the label expansion of Linzess, which will help drive its sales following successful development and potential approval.
Earlier this week, the company, along with partner AbbVie, announced that the FDA accepted and granted priority review to a supplemental new drug application (sNDA), seeking expanded use of Linzess for children and adolescents with functional constipation (“FC”). A final decision on the sNDA is expected in June 2023. FC currently has no FDA-approved therapies for children.
Other than Linzess, Ironwood is also evaluating two other pipeline candidates — IW-3300 and CNP-104 — for treating visceral pain conditions and primary biliary cholangitis, respectively. Management intends to start dosing study participants in the ongoing phase II proof-of-concept study evaluating IW-3300 in interstitial cystitis/bladder pain syndrome (“IC/BPS”) in early-2023.
Ironwood Pharmaceuticals, Inc. Price
Ironwood Pharmaceuticals, Inc. price | Ironwood Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Ironwood has a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Aeterna Zentaris (AEZS - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aeterna Zentaris loss per share estimates for 2023 have narrowed from $3.68 to $3.30 in the past 30 days. AEZS’s stock has plunged 62.6% in the past year.
Earnings of Aeterna Zentaris missed estimates in two of the last four quarters and met the mark on the other two occasions. On average, AEZS witnessed a trailing four-quarter positive earnings surprise of 7.72%, on average. In the last reported quarter, Aeterna Zentaris’ earnings missed estimates by 2.94%.