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Ironwood (IRWD) Q4 Earnings & Revenues Beat, Shares Rise

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Update time : 2019-06-11 19:22:59

Ironwood Pharmaceuticals, Inc. IRWD incurred fourth-quarter 2018 adjusted loss of 2 cents per share, narrower than the Zacks Consensus worth of a loss of 17 cents too during the loss of 14 cents at the year-ago period.

Total revenues at the fourth district were $130.7 million, reflecting a wave of 38.7% from the year-ago period, greatly due to Linzess’ (linaclotide) sales growth, border expansion and higher (active pharmaceutical ingredient) API sales to Astellas at Japan. The climax string too hit the Zacks Consensus worth of $86.72 million.

Shares of Ironwood were up approximately 11.7% following the news above Wednesday. at fact, the stock has inched up 1.8% at the past year versus the industry’s refuse of 17.8%.

Quarter at Detail

As reported by unite Allergan plc AGN, Ironwood’s key marketed produce — Linzess —generated net sales of $205.2 million at the United States, up 5.3% year above year. Ironwood and Allergan equally division brand collaboration profits or losses during Linzess.

Ironwood's division of net profits from sales of Linzess at the United States (included at collaborative revenues) was $81.6 million at the fourth quarter, up approximately 6.5% year above year. crude commercial advantage at the reported district was $146 million.

Sales of linaclotide API fragment added $45.9 million to revenues including sales to the company’s Japanese unite Astellas Pharma. The company too earned $3.2 million from linaclotide royalties, co-promotion and other revenues.

Per news provided by IQVIA (formerly Quintiles and IMS Health), Linzess prescriptions filled during the district were more than 868,000, up approximately 7% from the year-ago epoch cabin volume of prescribed Linzess capsules increased approximately 12%.

During the reported quarter, selling and administrative (SG&A) expenses inched up 0.5% to $58.2 million. investigation and development (R&D) expenses were $44.3 million, up 10.5% from the year-earlier period.

Restructuring Updates

The company is above explore to deduce its separation into two publicly trading entities at first-half 2019. final May, the company announced its intention to rip itself into two bodies during enhancing operational excellence and strategic flexibility. One part, which will last with the trend name, will concentrate above the commercial drugs and gastrointestinal (GI) pipeline development. cabin the other called Cyclerion will concentrate above developing the Soluble Guanylate Cyclase pipeline during treating earnest and orphan diseases. The part of the entities is too being anticipated to be tax-free.

Last month, Ironwood’s board announced the engagement of head executive officers (CEO) during the two new companies that will appear from the planned separation of the erstwhile Ironwood Pharma. during the new Ironwood, the company’s board has picked sign Mellon during its CEO. Meanwhile, Peter Hecht, the trend CEO of Ironwood Pharma is put to guide the new company — Cyclerion.

2019 Guidance

Ironwood expects crude revenues at the hill of $370-$390 million during 2019. Net advantage expenses are anticipated to be approximately $35 million. Separation expenses included within SG&A expenses are projected at the gang of $30-$40 million cabin restructuring expenses are predicted within $3-$4 million.

The company will supply its allowance anticipate during 2019 at a future investor update accident following the conclusion of the material separation.

Pipeline Updates

Linzess is approved at the United States during the treatment of adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Ironwood and Allergan are looking to increase Linzess’ label into additional symptoms and ripen the medication during a non-opioid, pain-relieving delegate during IBS patients.

Last July, Ironwood and Allergan initiated a phase IIIb program to worth a 290-mcg dose of Linzess during multiple abdominal symptoms at appendix to ache including bloating and discomfort at grown-up patients with irritable bowel syndrome along with constipation (IBS-C). Top-line news from the learn is expected by mid-2019.

The companies anticipate to begin a phase II analysis during the second district of 2019 during evaluating MD-7246 (delayed liberate formulation of Linzess) to treat crude subtypes of IBS including IBS-mixed and IBS with diarrhea.

Linzess is marketed by Allergan during IBS-C at Europe and Canada under the brand title Constella.

Last month, Ironwood and Allergan announced that both gorge settled crude pending patent litigations with Mylan Pharmaceuticals MYL related to Linzess. Mylan has filed an abbreviated new medication application (ANDA) seeking an approval to impartial a generic translation of Linzess. However, Mylan is cabin to accept an FDA nod during any generic translation of Linzess.

Last August, a label expansion of Linzess at the chronic constipation was approved at Japan. at China, Hong Kong and Macau, Ironwood has a marketing harmony with AstraZeneca AZN during Linzess. final month, Linzess was granted a marketing approval by Chinese regulatory authorities to treat adults with IBS-C. Ironwood plans to launch the medication at China along with AstraZeneca at the second half of 2019.

The company is too developing an interesting candidate called IW-3718. It is currently enrolling patients at two parallel phase III studies, evaluating IW-3718 during treating gastroesophageal reflux illness (GERD). Results from both studies are expected at the second half of 2020.

Praliciguat and olinciguat will be developed by the new entity, Cyclerion. A phase II learn is examining olinciguat during the latent treatment of sickle prison illness (SCD). Ironwood is currently enrolling patients at the well SCD phase II learn with outcomes awaited at the second half of 2019.

Two phase II investigations to estimate praliciguat during diabetic nephropathy and heart failure with preserved ejection part (HFpEF) are currently enrolling patients. Top-line findings from both studies are expected at the second half of 2019. final September, the FDA granted a quick explore designation to Praliciguat during a treatment option during HFpEF.

However, the company has notified its design to out-license praliciguat to a global unite ago progressing to phase III stage.

Late final month, Ironwood initiated a phase I probe above its orally administered, central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator, IW-6463. The candidate is currently being evaluated during the treatment of earnest and orphan CNS disorders at noise volunteers. news from this learn is anticipated during the second half of 2019.

IW-6463 is the first CNS-penetrant sGC simulator to enter clinical studies and is one of the five differentiated sGC stimulator programs. The identical will too be developed by Cyclerion.

Our Take

Linzess’ prospects appear encouraging due to well ask trends and the drug’s expansion to new patient population and geographies.

Meanwhile, the new Ironwood entity has high latent during it is expected to alter out to be a advantageous chance after the rip and its concentrate above gastrointestinal portfolio of commercial produce and pipeline appears impressive.

Moreover, the company’s $173.2 million cash estate during of final December-end and a well unite at Allergan bode well.

Ironwood Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Ironwood Pharmaceuticals, Inc. Price, Consensus and EPS surprise | Ironwood Pharmaceuticals, Inc. Quote

Zacks Rank

Ironwood currently carries a Zacks grade #3 (Hold).You can see the deduce list of today’s Zacks #1 grade (Strong Buy) stocks here.

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