Ironwood Slips into Loss in Q3 - Analyst Blog
October 23 2013 - 11:00AM
Zacks
Ironwood Pharmaceuticals, Inc.’s (IRWD)
third-quarter 2013 loss of 51 cents per share compared unfavorably
with the year-ago earnings of 42 cents per share. Results were
primarily hurt by lower revenues. The Zacks Consensus Estimate was
at a loss of 58 cents per share.
Total revenues in the third quarter of 2013 declined to $4.9
million from $96.4 million in the year-ago period. In the third
quarter of 2012, revenues were boosted by an $85 million milestone
payment from its partner Forest Laboratories, Inc.
(FRX). Revenues were below the Zacks Consensus Estimate of $7
million.
Linzess Update
Ironwood’s sole marketed product is Linzess indicated for irritable
bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). Ironwood co-markets the drug with Forest Labs.
Forest Labs and Ironwood share Linzess revenues generated in the
U.S. equally. Net sales of the drug, as reported by Forest Labs,
came in at $34.4 million in the third quarter of 2013 as compared
to $28.8 million in the preceeding quarter.
In the third quarter, the number of prescriptions filed increased
by more than 40% to 178,000. The company is focusing on promoting
the product to gastroenterologists and primary care physicians. The
company is also working on expanding managed care access to Linzess
and lowering the out-of-pocket cost borne by patients.
Approximately 80% patients who are covered by commercial insurance
plans have unrestricted access to Linzess, while approximately 60%
have tier II ($30 co-pay) access as of Sep 2013. Ironwood’s
Medicare part D plan covers approximately 15% – 20% of the targeted
patient population.
Ironwood is looking to broaden Linzess’ label by expanding the
targeted patient population and gaining approval for additional
indications. The company is evaluating Linzess for abdominal
symptoms in patients with CIC in a phase IIIb trial. Top-line data
from the trial suggest encouraging efficacy. The study met its
primary endpoint. Ironwood also intends to evaluate Linzess in
pediatric patients and for opioid-induced constipation (phase IIa
study expected to be initiated in the first half of 2014), both of
which represent significant commercial opportunity.
In the EU, approval came in Nov 2012 under the trade name
Constella. Ironwood is collaborating with Almirall, S.A. in the EU
for the drug.
Ironwood is also working with its Japanese partner, Astellas, for
the development of Linzess in Japan, South Korea, Taiwan, Thailand,
the Philippines and Indonesia and with AstraZeneca
(AZN) in China, Hong Kong and Macau. Currently, Astellas is
evaluating the drug in a phase II trial for IBS-C with results
expected this year (enrollment complete). Ironwood and AstraZeneca
started enrolling patients in a phase III trial evaluating
linaclotide in adult IBS-C patients in Aug 2013 with data expected
in the first half of 2015.
Expenses
During the third quarter of 2013, selling, general and
administrative (SG&A) expenses surged 32.5% to $30.3 million.
For 2013, Ironwood expects total investment in sales and marketing
for Linzess on the lower end of the $250–$300 million range.
Research and development (R&D) expenses amounted to $23
million, up 0.7%. In 2013, Ironwood expects to invest in the lower
end of the $60–$75 million range in R&D expenses not pertaining
to linaclotide.
Ironwood carries a Zacks Rank #3 (Hold). We expect investor focus
to remain on the market performance of Linzess. Currently,
companies like Roche (RHHBY) look well positioned
with a Zacks Rank #1 (Strong Buy).
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
ROCHE HLDG LTD (RHHBY): Get Free Report
To read this article on Zacks.com click here.
Zacks Investment Research
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024