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Ironwood Rides on Linzess' Progress, Stalls Lenisurad Drugs
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On Oct 16, we issued an updated research report on Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) . This biopharmaceutical company, based in Cambridge, MA, is focused on the development and commercialization of treatments primarily addressing gastrointestinal (“GI”) diseases. The company’s sole marketed drug, Linzess, is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (“CIC”).
We remind investors that Ironwood co-develops and co-commercializes Linzess and equally shares Linzess U.S. collaboration profits/losses as well as development costs with Allergan .
Linzess Continues to Perform Well
Sales of Linzess continue to be impressive in 2018. The drug’s sales rose 11.3% in the first six months of 2018. The rise in sales increased Ironwood’s collaboration revenues by 23.3% to $130.4 million in the same period. Prescriptions filled in the first half of 2018 were also up approximately 8% year over year.
The company also earns by selling linaclotide (Linzess) API to Japan-based Astellas Pharma. Ironwood Pharma generated almost $14.2 million from this transaction in the first half of 2018 compared with $6 million in the year-ago period. Astellas Pharma started commercializing Linzess in Japan for IBS-C since early 2017. Meanwhile, a label expansion in chronic constipation was approved in August. This will further boost API sales.
In July 2018, Ironwood and Allergan initiated a phase III study to evaluate Linzess in additional abdominal symptoms including bloating and discomfort in adult patients with IBS-C. A phase IIb study is currently being designed, which will evaluate delayed-release formulation of Linzess as a treatment for all subtypes of IBS, including IBS-C, IBS with diarrhea and IBS-mixed.
However, .competition in Linzess’ target market has intensified, with Synergy Pharmaceuticals’ Trulance receiving approval for CIC in 2017 and IBS-C in early 2018.
Pipeline Progress
Apart from Linzess, Ironwood is also developing other pipeline candidates, which include one gastro-intestinal (“GI”) candidate and two soluble guanylate cyclase (sGC) stimulators.
Ironwood Pharma’s GI candidate, IW-3718, is being developed for treating persistent gastroesophageal reflux disease in a phase III study. A successful development will enable the company to serve a market of approximately 10 million American patients suffering from heartburn and regurgitation despite receiving treatment with proton pump inhibitors.
Ironwood Pharma’s two sGC candidates – praliciguat and olinciguat – are in phase II studies. Data from praliciguat studies, evaluating it in diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF), is expected in second half of 2019. In September, the FDA granted Fast Track designation to praliciguat for the treatment of HFpEF. Data from the study evaluating olinciguat in achalasia is expected in the second half of 2018. In June, the FDA granted Orphan Drug status to the candidate for the treatment of sickle cell disease.
Restructuring Initiatives
Although Ironwood Pharma’s progress with Linzess and its pipeline has been impressive so far, the company’s lenisurad franchise has been performing below expectations. Sales of Zurampic and Duzallo, two drugs from the franchise, increased $1 million year over year to $1.7 million in the first half of 2018 mainly driven by Duzallo, launched in October 2017.
In July, the company sent a notice of termination to AstraZeneca (AZN - Free Report) due to unfavorable data from a marketing study evaluating the franchise’s path forward.
Following this, Ironwood Pharma reduced its projected revenue and net cash flow assumptions from Zurampic and Duzallo for 2018. Moreover, upon completion of the termination of lenisurad franchise, the company will solely depend on Linzess for the majority of its revenues.
Meanwhile, Ironwood Pharma is also undertaking other restructuring initiatives to save operating expenses. It reduced its employee count by 185 related to lesinuard franchise, which is expected to save operating expenses of approximately $75 million to $100 million in 2019.
Ironwood Pharma will split itself into two separate entities to achieve increased operational performance and strategic flexibility. One entity will focus on Linzess and GI pipeline development and the other entity will focus on the development of the sGC pipeline for the treatment of serious and orphan diseases. The transaction is expected to close in the first half of 2019.
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Ironwood Rides on Linzess' Progress, Stalls Lenisurad Drugs
On Oct 16, we issued an updated research report on Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) . This biopharmaceutical company, based in Cambridge, MA, is focused on the development and commercialization of treatments primarily addressing gastrointestinal (“GI”) diseases. The company’s sole marketed drug, Linzess, is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (“CIC”).
We remind investors that Ironwood co-develops and co-commercializes Linzess and equally shares Linzess U.S. collaboration profits/losses as well as development costs with Allergan .
Linzess Continues to Perform Well
Sales of Linzess continue to be impressive in 2018. The drug’s sales rose 11.3% in the first six months of 2018. The rise in sales increased Ironwood’s collaboration revenues by 23.3% to $130.4 million in the same period. Prescriptions filled in the first half of 2018 were also up approximately 8% year over year.
The company also earns by selling linaclotide (Linzess) API to Japan-based Astellas Pharma. Ironwood Pharma generated almost $14.2 million from this transaction in the first half of 2018 compared with $6 million in the year-ago period. Astellas Pharma started commercializing Linzess in Japan for IBS-C since early 2017. Meanwhile, a label expansion in chronic constipation was approved in August. This will further boost API sales.
In July 2018, Ironwood and Allergan initiated a phase III study to evaluate Linzess in additional abdominal symptoms including bloating and discomfort in adult patients with IBS-C. A phase IIb study is currently being designed, which will evaluate delayed-release formulation of Linzess as a treatment for all subtypes of IBS, including IBS-C, IBS with diarrhea and IBS-mixed.
However, .competition in Linzess’ target market has intensified, with Synergy Pharmaceuticals’ Trulance receiving approval for CIC in 2017 and IBS-C in early 2018.
Pipeline Progress
Apart from Linzess, Ironwood is also developing other pipeline candidates, which include one gastro-intestinal (“GI”) candidate and two soluble guanylate cyclase (sGC) stimulators.
Ironwood Pharma’s GI candidate, IW-3718, is being developed for treating persistent gastroesophageal reflux disease in a phase III study. A successful development will enable the company to serve a market of approximately 10 million American patients suffering from heartburn and regurgitation despite receiving treatment with proton pump inhibitors.
Ironwood Pharma’s two sGC candidates – praliciguat and olinciguat – are in phase II studies. Data from praliciguat studies, evaluating it in diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF), is expected in second half of 2019. In September, the FDA granted Fast Track designation to praliciguat for the treatment of HFpEF. Data from the study evaluating olinciguat in achalasia is expected in the second half of 2018. In June, the FDA granted Orphan Drug status to the candidate for the treatment of sickle cell disease.
Restructuring Initiatives
Although Ironwood Pharma’s progress with Linzess and its pipeline has been impressive so far, the company’s lenisurad franchise has been performing below expectations. Sales of Zurampic and Duzallo, two drugs from the franchise, increased $1 million year over year to $1.7 million in the first half of 2018 mainly driven by Duzallo, launched in October 2017.
In July, the company sent a notice of termination to AstraZeneca (AZN - Free Report) due to unfavorable data from a marketing study evaluating the franchise’s path forward.
Following this, Ironwood Pharma reduced its projected revenue and net cash flow assumptions from Zurampic and Duzallo for 2018. Moreover, upon completion of the termination of lenisurad franchise, the company will solely depend on Linzess for the majority of its revenues.
Meanwhile, Ironwood Pharma is also undertaking other restructuring initiatives to save operating expenses. It reduced its employee count by 185 related to lesinuard franchise, which is expected to save operating expenses of approximately $75 million to $100 million in 2019.
Ironwood Pharma will split itself into two separate entities to achieve increased operational performance and strategic flexibility. One entity will focus on Linzess and GI pipeline development and the other entity will focus on the development of the sGC pipeline for the treatment of serious and orphan diseases. The transaction is expected to close in the first half of 2019.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>