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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ironwood Pharmaceuticals Inc | NASDAQ:IRWD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.18 | -2.17% | 8.12 | 8.10 | 8.32 | 8.45 | 8.10 | 8.45 | 1,863,457 | 21:43:22 |
– LINZESS® (linaclotide) expanded IBS-C/CIC branded prescription market leadership in 2Q 2017 with 19% growth in volume year-over-year and $168 million in U.S. net sales –
– Positive IW-3718 Phase IIb top-line data in uncontrolled GERD support advancement into Phase III –
– Multiple additional catalysts expected in 2H 2017, including DUZALLO® (lesinurad and allopurinol) approval and launch, three mid-stage data readouts and four mid- to late-stage trial initiations –
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, today provided an update on its second quarter 2017 results and recent business activities.
“Our performance in the first half of 2017 reinforces the potential for our commercial products and mid- to late-stage pipeline to efficiently grow large consumer-driven patient categories and help millions of patients for years to come,” said Peter Hecht, chief executive officer of Ironwood. “We expect LINZESS and DR1, if approved, to coexist as leading products and grow the IBS-C/CIC category into the 2030s. IW-3718, if approved, has the opportunity to build and grow the uncontrolled GERD market, and is a strong fit with our U.S. commercial capabilities. These assets, combined with DUZALLO, DR2 and our sGC stimulators, position us well to continue to deliver new medicines to patients and accelerate high-margin growth for our fellow shareholders.”
Second Quarter 2017 and Recent Highlights
Irritable Bowel Syndrome with Constipation (IBS-C) / Chronic Idiopathic Constipation (CIC)
Uncontrolled Gout
Uncontrolled Gastroesophageal Reflux Disease (GERD)
Vascular and Fibrotic Diseases
Global Collaborations and Partnerships
Corporate and Financials
Non-GAAP Financial Measures
The company presents non-GAAP net loss and non-GAAP net loss per share to exclude the impact of net gains and losses on the derivatives related to our convertible notes that are required to be marked-to-market, as well as the amortization of acquired intangible assets and the fair value remeasurement of contingent consideration associated with Ironwood’s U.S. licensing agreement with AstraZeneca for the exclusive rights to all products containing lesinurad. The derivative gains and losses may be highly variable, difficult to predict and of a size that could have a substantial impact on the company’s reported results of operations in any given period. The acquired intangible assets are valued as of the date of acquisition and are amortized over their estimated economic useful life, and management believes excluding the amortization of acquired intangible assets provides more consistency with the treatment of internally developed intangible assets for which research and development costs were previously expensed. The contingent consideration balance is remeasured each reporting period, and the resulting change in fair value impacts the company’s reported results of operations. The changes in the fair value remeasurement of contingent consideration do not correlate to the company’s actual cash payment obligations in the relevant period. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.
Conference Call Information
Ironwood will host a conference call and webcast at 4:30 p.m. Eastern Time on Thursday, August 3, 2017 to discuss its second quarter of 2017 results and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552 (international) using conference ID number 51693981. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 7:30 p.m. Eastern Time, on August 3, 2017 running through 11:59 p.m. Eastern Time on August 10, 2017. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 51693981. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are commercializing two innovative primary care products: linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and lesinurad, which is approved to be taken with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with uncontrolled gout. We are also advancing a pipeline of internally and externally generated innovative product candidates in areas of significant unmet need, including uncontrolled gastroesophageal reflux disease and vascular and fibrotic diseases. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), based on QuintilesIMS data. Since its FDA approval in August of 2012 and subsequent launch in December 2012, greater than 1.5 million unique patients have filled more than 8 million prescriptions for LINZESS, according to QuintilesIMS.
LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years if age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In the United States, Ironwood and Allergan plc co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, Allergan markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide in China, and with Allergan for development and commercialization of linaclotide in all other territories worldwide.
About ZURAMPIC (lesinurad) 200mg tablets
ZURAMPIC (lesinurad) works in combination with xanthine oxidase inhibitors (XOIs) to treat hyperuricemia associated with uncontrolled gout. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy. XOIs reduce the production of uric acid; ZURAMPIC increases the excretion of uric acid. Together, the combination of ZURAMPIC and an XOI provides a dual mechanism of action that both decreases production and increases excretion of uric acid, thereby lowering serum uric acid (sUA) levels in patients who have not achieved target serum uric acid levels with XOI treatment alone. ZURAMPIC selectively inhibits the function of transporter proteins uric acid transporter 1 (URAT1) and organic anion transporter 4 (OAT4), involved in uric acid reabsorption in the kidney. The safety and efficacy of ZURAMPIC was established in three Phase III clinical trials that evaluated a once-daily dose of ZURAMPIC in combination with the XOI allopurinol or febuxostat compared to XOI alone. The boxed warning for ZURAMPIC states that acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone and reinforces that ZURAMPIC should be used in combination with an XOI.
LINZESS Important Safety Information
INDICATIONS AND USAGELINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.Contraindications
Warnings and PrecautionsPediatric Risk
Diarrhea
Common Adverse Reactions (incidence ≥2% and greater than placebo)
Please see full Prescribing Information including Boxed Warning:http://www.allergan.com/assets/pdf/linzess_pi
ZURAMPIC Important Safety Information and Limitations of Use
WARNING: RISK OF ACUTE RENAL FAILURE MORE COMMON WHEN USEDWITHOUT A XANTHINE OXIDASE INHIBITOR (XOI)
• Acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone
• ZURAMPIC should be used in combination with an XOI
Contraindications:
Warnings and Precautions:
Adverse Reactions:
Indication and Limitations of Use for ZURAMPIC
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with an XOI alone.
Please see full Prescribing Information, including Boxed Warning, at:http://www.azpicentral.com/zurampic/zurampic.pdf.
VIBERZI Important Safety Information
Contraindications
Warnings and PrecautionsSphincter of Oddi Spasm:
Pancreatitis:
Adverse Reactions
Please see full Prescribing Information for VIBERZI:http://www.allergan.com/assets/pdf/viberzi_pi.
LINZESS® and CONSTELLA® are trademarks of Ironwood Pharmaceuticals, Inc., and ZURAMPIC® and DUZALLO® are trademarks of AstraZeneca AB. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the development, launch, commercial availability and commercial potential of linaclotide, lesinurad, our product candidates and the other products that we promote and the drivers, timing, impact and results thereof (including pipeline catalysts); market size, prevalence, growth and opportunity, including peak sales (and drivers thereof) and the growth in and potential demand for linaclotide, lesinurad and our product candidates, as well as their potential impact on applicable markets; the potential indications for, and benefits of, linaclotide, lesinurad and our product candidates; the anticipated timing of preclinical, clinical and regulatory developments and the design, timing and results of clinical and preclinical studies (including engaging with the FDA and defining primary and secondary endpoints); the potential for, and timing of, regulatory submissions and approvals for linaclotide, lesinurad and our product candidates; expected periods of patent exclusivity and life of the respective patent portfolios for linaclotide, lesinurad and our product candidates; commercial strategy, including market development, the potential for broad access and reimbursement, refreshing our DTC campaign, fit within our U.S. commercial capabilities, and intentions related to commercializing IW-3718 within and outside the U.S.; comparisons related to net sales and volume; the strength of the intellectual property protection for linaclotide, lesinurad and our product candidates and our intentions and efforts to protect such intellectual property; our potential for sustainable, high-margin growth and shareholder returns; and our financial performance and results, and guidance and expectations related thereto (including the drivers and timing thereof), including expectations related to Ironwood revenue CAGR and revenue growth, LINZESS U.S. net sales, growth and net price, R&D, SG&A and marketing and sales expenses, net interest expense and cash used for operations. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development; our reliance on AstraZeneca to provide critical support services related to lesinurad; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability of linaclotide, lesinurad and our product candidates; decisions by regulatory authorities; the risk that we are unable to successfully integrate lesinurad into our existing business, commercialize lesinurad or realize the anticipated benefits of the lesinurad transaction; the risk that we may never get sufficient patent protection for linaclotide and our product candidates or that we are not able to successfully protect such patents; the outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including ANDA litigation; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues, linaclotide, lesinurad or our product candidates; the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, and in our subsequent SEC filings. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Further, Ironwood considers the net profit for the U.S. LINZESS brand collaboration with Allergan in assessing the product's performance and calculates it based on inputs from both Ironwood and Allergan. This figure should not be considered a substitute for Ironwood's GAAP financial results. An explanation of our calculation of this figure is provided in the U.S. LINZESS Brand Collaboration table and related footnotes accompanying this press release.
Condensed Consolidated Balance Sheets
(In thousands)
(unaudited)
June 30,2017
December 31, 2016
Assets Cash, cash equivalents and available-for-sale securities $ 272,895 $ 305, 216 Accounts receivable, net 60,357 64,854 Inventory - 1,081 Prepaid expenses and other current assets 8,235 9,030 Total current assets 341,487 380,181 Property and equipment, net 17,854 20,512 Convertible note hedges 171,880 132,521 Intangible assets, net 165,278 166,119 Goodwill 785 785 Other assets 7,795 9,703 Total assets $ 705,079 $ 709,821 Liabilities and Stockholders’ Equity Accounts payable, accrued expenses and other current liabilities $ 59,461 $ 62,941 Current portion of capital lease obligations 5,097 6,227 Current portion of deferred rent 205 7,719 Current portion of deferred revenue 225 - Current portion of contingent consideration 14,985 14,244 Total current liabilities 79,973 91,131 Capital lease obligations - 82 Deferred rent, net of current portion 3,515 557 Other liabilities 8,190 8,190 Contingent consideration, net of current portion 71,213 63,416 Note hedge warrants 149,458 113,237 Convertible notes 241,544 234,243 Long-term debt 146,316 132,249 Total stockholders’ equity 4,870 66,716 Total liabilities and stockholders’ equity $ 705,079 $ 709,821Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
Three Months EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 Total revenues $ 65,077 $ 54,350 $ 117,243 $ 120,392 Cost and expenses: Cost of revenues, excluding amortization of acquired intangible asset 3,502 - 4,033 - Write-down of lesinurad commercial supply to net realizable value 96 - 96 - Research and development 37,344 31,682 71,046 63,524 Selling, general and administrative 57,792 36,918 113,396 73,086 Amortization of acquired intangible asset 421 1,065 841 1,065 Loss on fair value remeasurement of contingent consideration 6,933 - 8,547 - Total cost and expenses 106,088 69,665 197,959 137,675 Loss from operations (41,011 ) (15,315 ) (80,716 ) (17,283 ) Other (expense) income: Interest expense, net (8,550 ) (9,532 ) (17,138 ) (19,218 ) Loss on extinguishment of debt - - (2,009 ) - Gain on derivatives 5,337 3,145 3,138 1,502 Other expense, net (3,213 ) (6,387 ) (16,009 ) (17,716 ) GAAP net loss $ (44,224 ) $ (21,702 ) $ (96,725 ) $ (34,999 ) GAAP net loss per share—basic and diluted $ (0.30 ) $ (0.15 ) $ (0.65 ) $ (0.24 ) Three Months EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 Non-GAAP net loss $ (42,207 ) $ (23,782 ) $ (90,475 ) $ (35,436 ) Non-GAAP net loss per share (basic and diluted) $ (0.28 ) $ (0.16 ) $ (0.61 ) $ (0.25 )Weighted average number of common shares used in net loss
per share — basic and diluted
148,778
144,642
148,285
144,118
Reconciliation of GAAP Results to Non-GAAP Financial Measures
(In thousands, except per share amounts)
(unaudited)
A reconciliation between net loss on a GAAP basis and on a non-GAAP basis is as follows:
Three Months EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 GAAP net loss $ (44,224 ) $ (21,702 ) $ (96,725 ) $ (34,999 ) Adjustments: Mark-to-market adjustments on the derivatives related to convertible notes, net (5,337 ) (3,145 ) (3,138 ) (1,502 ) Amortization of intangible asset 421 1,065 841 1,065 Fair value remeasurement of contingent consideration 6,933 - 8,547 - Non-GAAP net loss $ (42,207 ) $ (23,782 ) $ (90,475 ) $ (35,436 )A reconciliation between diluted net loss per share on a GAAP basis and on a non-GAAP basis is as follows:
Three Months EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 GAAP net loss per share – Basic and Diluted $ (0.30 ) $ (0.15 ) $ (0.65 ) $ (0.24 ) Adjustments to GAAP net loss per share (as detailed above) 0.01 (0.01 ) 0.04 (0.01 )Non-GAAP net loss per share – basic and diluted1
$ (0.28 ) $ (0.16 ) $ (0.61 ) $ (0.25 )1 Numbers may not add due to rounding.
U.S. LINZESS Brand Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
Three Months EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 LINZESS U.S. net sales $ 167,833 $ 150,464 $ 315,448 $ 287,601Commercial costs and expenses2
80,211 71,556 151,140 133,705 Commercial profit on sales of LINZESS $ 87,622 $ 78,908 $ 164,308 $ 153,896Commercial Margin3
52% 52% 52% 54% Ironwood’s share of net profit $ 43,811 $ 39,454 $ 82,154 $ 76,948Ironwood’s selling, general and administrative expenses4
12,496 8,879 23,605 18,032 Ironwood’s collaborative arrangement revenue $ 56,307 $ 48,333 $ 105,759 $ 94,9801 Ironwood collaborates with Allergan on the development and commercialization of linaclotide in North America. Under the terms of the collaboration agreement, Ironwood receives 50% of the net profits and bears 50% of the net losses from the commercial sale of LINZESS in the U.S. The purpose of this table is to present calculations of Ironwood’s share of net profit (loss) generated from the sales of LINZESS in the U.S. and Ironwood’s collaboration revenue/expense; however, the table does not present the research and development expenses related to LINZESS in the U.S. that are shared equally between the parties under the collaboration agreement. For the three months ended June 30, 2017, net profit for the U.S. LINZESS brand collaboration with Allergan was $72.2 million, calculated by subtracting $80.2 million in commercial costs and expenses and $15.4 million in research and development expenses, from LINZESS U.S. net sales of $167.8 million.2 Includes cost of goods sold incurred by Allergan as well as selling, general and administrative expenses incurred by Allergan and Ironwood that are attributable to the cost-sharing arrangement between the parties.3 Commercial margin is defined as commercial profit on sales of LINZESS as a percent of total LINZESS U.S. net sales.4 Includes Ironwood’s selling, general and administrative expenses attributable to the cost-sharing arrangement with Allergan.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170803006233/en/
Ironwood Pharmaceuticals, Inc.Meredith Kaya, 617-374-5082Senior Director, Investor Relations and Corporate Communicationsmkaya@ironwoodpharma.com
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