Actionable news
0
All posts from Actionable news
Actionable news in IRWD: Ironwood Pharmaceuticals, Inc.,

Ironwood: Third Quarter 2015 Investor Update

The following excerpt is from the company's SEC filing.

LINZESS® (linaclotide) prescriptions increased approximately 38% to over 550 thousand in third quarter 2015 compared to third quarter 2014

LINZESS U.S. net sales increased approximately 47% to $117.5 million in third quarter 2015 compared to third quarter 2014

Ironwood revenue increased approximately 134% to $39.6 million in third quarter 2015 compared to third quarter 2014

Multiple positive development milestones including linaclotide 72mcg Phase III data, initiation of Phase IIb linaclotide colonic release trial, and advancement of sGC platform

CAMBRIDGE, Mass., Novemb er 3, 2015

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its third quarter 2015 and recent business activities.

We had another very strong quarter at Ironwood. With excellent performance across all facets of our company, we believe that the growing contribution from our commercial business and cash on hand enables us to fully fund our current business without the need to raise additional capital, said Peter Hecht, chief executive officer of Ironwood.

Third Quarter 2015 and Recent Highlights

LINZESS U.S. net sales, as provided by Allergan plc, were $117.5 million in the third quarter of 2015, an approximately 47% increase compared to the third quarter of 2014.

More than 550,000 total LINZESS prescriptions were filled in the third quarter of 2015, an approximately 38% increase compared to the third quarter of 2014, and more than 3.5 million LINZESS prescriptions have been filled since the products launch in December 2012, according to IMS Health.

Net profit for the LINZESS brand collaboration in the U.S., including commercial costs and expenses and research and development (R&D) expenses, was $35.8 million in the third quarter of 2015. LINZESS U.S. net profit is shared equally with Allergan.

More than 150,000 healthcare practitioners have prescribed LINZESS to more than 825,000 unique patients since the products launch, according to IMS Health.

More than 70% of people with commercial insurance or Medicare Part D plans had unrestricted access to LINZESS as of October 2015. Additionally, as of September 2015, more than 80% of people with commercial insurance had access to LINZESS for a co-pay of $30 or less through formulary coverage or the LINZESS Instant Savings Program.

Research & Development

Ironwood continues to progress its innovative pipeline. To date in 2015, 12 clinical studies have been advanced, including four studies for wholly-owned programs and eight studies for partnered programs. In addition, Ironwood has reported positive top-line data from four studies: the Phase III linaclotide 72 mcg trial, the Phase III linaclotide trial for China, the Phase IIa IW-3718 study, and the Phase Ia IW-1973 study.

Ironwood and Allergan continue to evaluate opportunities to strengthen the clinical utility of linaclotide in its indicated patient population and to develop linaclotide in additional indications, patient populations and formulations. Development highlights during the third quarter and recent period include:

Reported positive top-line results from the Phase III clinical trial assessing the efficacy and safety of a once-daily 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation (CIC). The trial met the primary endpoint with statistical significance. Diarrhea, the most common adverse event reported in this trial, was characterized as mild in severity. In this trial, the rates of diarrhea and of discontinuations due to diarrhea were lower for the 72 mcg dose than the currently approved 145 mcg dose. Ironwood and Allergan expect to submit the supplemental new drug application for the 72 mcg dose to the U.S. Food and Drug Administration in the first half of 2016. If approved, the 72 mcg dose should accelerate physician prescribing of LINZESS within the broad, heterogeneous adult CIC patient population by providing them with an additional dosing option.

Initiated a randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating two linaclotide colonic release formulations in adult patients with irritable bowel syndrome with constipation (IBS-C). This trial will evaluate the safety, efficacy and dose-response of the two colonic release formulations as well as how they compare to each other and to the approved 290 mcg formulation of linaclotide. Data from this trial are anticipated in the second half of 2016.

Initiated two randomized, double-blind, placebo-controlled Phase II studies evaluating linaclotide in the pediatric population. The first study is in IBS-C patients aged 7 to 17 years old and the second is in patients with functional constipation aged 6 to 17 years old.

Completed enrollment in the Phase II clinical study evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data from this study are expected in the fourth quarter of 2015.

Ironwood continues to advance its pipeline of gastrointestinal (GI) product candidates and its soluble guanylate cyclase (sGC) program. Development highlights during the third quarter and recent period include:

Continued advancement of the Phase IIa clinical study evaluating the ability of IW-9179 to provide relief of diabetic gastroparesis symptoms. IW-9179 is a guanylate cyclase-C (GC-C) agonist designed to target the upper GI tract. Data from this study are expected in the first half of 2016.

Advanced IW-1973 and IW-1701, the first two candidates from its sGC stimulator platform. The company initiated a randomized, double-blind, placebo-controlled, multiple-ascending dose Phase Ib clinical study with IW-1973. This study is designed to assess the safety, pharmacokinetic profile and pharmacodynamics effects of IW-1973 in healthy volunteers. Data from this study are expected in the second half of 2016. In addition, the company initiated a randomized, double-blind, placebo-controlled, single-ascending dose Phase Ia clinical study with IW-1701. This study is designed to assess the safety, pharmacokinetic profile and pharmacodynamics effects of IW-1701 in healthy volunteers. Data from this study are expected in the first half of 2016.

Finalizing preparations for the IW-3718 dose-ranging Phase IIb study for the potential treatment of refractory GERD, which is expected to initiate in early 2016.

Global Partnerships for Linaclotide

In October 2015, Allergan acquired Almiralls exclusive rights to develop and commercialize linaclotide in the European Union, Switzerland, Turkey and the Commonwealth of Independent States for the treatment of IBS-C, CIC and other GI conditions. Allergan also reacquired all rights from Almirall to LINZESS in Mexico. Under the terms of the amended arrangement with Allergan, Ironwood is eligible for launch- and sales-based milestones from Allergan, as well as royalties on net sales of linaclotide in these countries.

Ironwood and AstraZeneca AB intend to file for approval to market linaclotide with the China Food and Drug Administration in the first quarter of 2016.

Astellas Pharma Inc. completed enrollment in its Phase III clinical trial of linaclotide in adult patients with IBS-C for Japan, with data expected in late 2015. In addition, Astellas also continues to enroll patients in its Phase II clinical study of linaclotide in adult patients with chronic constipation for Japan, and expects to complete the study in 2016.

U.S. Commercial Capabilities

Ironwood has built a strong U.S. commercial organization that successfully introduced LINZESS to the market and will serve as the foundation to support the potential commercialization of multiple important products in the U.S. over time.

Ironwood and Exact Sciences Corp. are co-promoting Exact Sciences Cologuard

, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. Ironwoods clinical sales specialists began promoting Cologuard in April 2015. As of mid-September 2015, approximately 4,200 healthcare practitioners on whom the Ironwood

clinical sales specialists have called have ordered a Cologuard test kit, as provided by Exact Sciences.

Ironwood and Allergan expect to begin co-promoting VIBERZI (eluxadoline) by the end of November 2015. The companies entered into an agreement in August 2015 for the U.S. co-promotion of VIBERZI, Allergans new treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Ironwoods clinical sales specialists will detail VIBERZI to the approximately 25,000 health care practitioners to whom they currently detail LINZESS and Cologuard.

Corporate and Financials

Collaborative Arrangements Revenue.

Collaborative arrangements revenue was approximately $39.6 million in the third quarter of 2015 compared to approximately $16.9 million in the third quarter of 2014. Revenue consisted of approximately $34.8 million in revenue associated with Ironwoods share of the net profits and losses from the sales of LINZESS in the U.S., as well as approximately $4.8 million in revenues associated with Ironwoods co-promotion agreement with Exact Sciences, amortization of deferred revenue associated with consideration received from Ironwoods collaboration with Astellas, revenue recognized in connection with the collaboration with AstraZeneca, and royalty payments based on sales of linaclotide in territories outside of the U.S.

Operating Expenses.

Operating expenses were approximately $56.3 million in the third quarter of 2015 as compared to approximately $53.6 million in the third quarter of 2014. Operating expenses in the third quarter of 2015 consisted of approximately $25.8 million in R&D expenses, and approximately $30.5 million in selling, general and administrative (SG&A) expenses. Non-cash share-based compensation expenses recorded in R&D and SG&A expenses in the third quarter of 2015 were approximately $2.7 million and $4.0 million, respectively.

Loss on Non-cancelable Purchase Commitments.

Our loss on non-cancelable purchase commitments of approximately $9.4 million in the third quarter primarily relates to the amended European license arrangement with Allergan. Under the terms of the amended arrangement, Allergan assumed responsibility for the...


More