On Thursday, Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) shares price traded between $18.42 and $19.23 during the last trading session upbeat with +1.28% at $18.95. The shares recorded trading volume 884,942 shares as compared to its average volume of 1,486,051 shares. The company has 137.94M shares outstanding and market value of 2.879B. Over the one year trading period, the stock has a peak price of $19.79 and its down is recorded at $12.89.
Ironwood Pharmaceuticals, Inc. (IRWD) recently provided an update on its first quarter 2018 results and recent business activities.
First Quarter 2018 and Recent Highlights
Irritable Bowel Syndrome with Constipation (IBS-C) / Chronic Idiopathic Constipation (CIC)
- S. LINZESS.U.S. net sales, as stated by Ironwood’s U.S. alliance partner Allergan plc, were $159.3M in the first quarter of 2018, an 8% raise contrast to the first quarter of 2017. Ironwood and Allergan share equally in brand alliance profits.
- LINZESS commercial margin was 63% in the first quarter of 2018 contrast to 52% in the first quarter of 2017.
- Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (R&D) expenses, was $88.8M in the first quarter of 2018, a 43% raise contrast to the first quarter of 2017.
- Total LINZESS prescription volume in the first quarter of 2018 included about 30M LINZESS capsules, an 15% raise in capsules contrast to the first quarter of 2017, per IQVIA.
- Over 764,000 total LINZESS prescriptions were filled in the first quarter of 2018, an about 9% raise contrast to the first quarter of 2017, per IQVIA.
- Since the launch of LINZESS in December 2012, greater than 2M exclusive patients have filled about 10.6M prescriptions, per IQVIA.
- In January 2018, Ironwood and Allergan reached an contract with wholly-owned subsidiaries of Sun Pharmaceutical Industries Ltd. (Sun Pharma, including its subsidiaries and/or associated companies), resolving patent litigation brought in response to Sun Pharma’s abbreviated new drug application (ANDA) seeking authorization to market a generic version of LINZESS previousto the expiration of the companies’ patents. Pursuant to the terms of the settlement, Ironwood and Allergan will grant the wholly-owned subsidiaries of Sun Pharma a license to market a generic version of LINZESS in the U.S. startning on February 1, 2031 (subject to U.S. FDA authorization ), unless certain limited circumstances, customary for settlement contracts of this nature, occur. As a result of the settlement, all Hatch-Waxman litigation between the companies and Sun Pharma regarding LINZESS patents has been dismissed.
- Additional Abdominal Symptom Claims. Ironwood and Allergan expect to initiate a single Phase III trial with LINZESS in mid-2018 to evaluate its efficacy for relief of additional abdominal symptoms, including bloating and discomfort, two highly bothersome symptoms associated with IBS-C.
- Linaclotide Delayed Release. An estimated 20 to 25M patients suffer from IBS-mixed and IBS with diarrhea in the U.S. Ironwood and Allergan plan to advance into a Phase IIb clinical trial a linaclotide delayed release formulation as a potential visceral, non-opioid, pain-relieving agent for patients suffering from all subtypes of IBS. The companies are in active discussions with the U.S. FDA about this program.
- LINZESS-Japan.Ironwood stated $5.4M in sales of linaclotide active pharmaceutical ingredient (API) to its Japanese partner, Astellas Pharma Inc. in the first quarter of 2018.
Corporate and Financials
- Total Revenues
- Total revenues were $69.2M in the first quarter of 2018 contrast to $52.2M in the first quarter of 2017. Included in total revenues was $61.2M associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., $5.4M in sales of linaclotide API to Astellas, $0.6M in ZURAMPIC and DUZALLO product revenue, and $2.0M in linaclotide royalties, co-promotion and other revenue.
- Operating Expenses
- Operating expenses were $105.0M in the first quarter of 2018, contrast to $91.8M in the first quarter of 2017. Operating expenses in the first quarter of 2018 included $2.6M in cost of revenues, $36.5M in R&D expenses, $61.9M in selling, general and administrative (SG&A) expenses, of which $2.4M related to Ironwood’s field-based workforce reduction in January 2018, $3.5M in purchased intangible assets amortization expenses, and a $0.5M loss on fair value re-measurement of contingent consideration.
- Contingent consideration and amortization of purchased intangible assets relate to Ironwood’s license contract with AstraZeneca for the exclusive U.S. rights to all products containing lesinurad.
- GAAP net loss was $43.1M, or $0.29 per share, in the first quarter of 2018, contrast to a net loss of $52.5M, or $0.36 per share, in the first quarter of 2017.
- Non-GAAP net loss was $40.5M, or $0.27 per share, in the first quarter of 2018, contrast to $48.3M, or $0.33 per share, in the first quarter of 2017. Non-GAAP net loss excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s convertible debt, as well as the amortization of purchased intangible assets and the fair value re-measurement of contingent consideration related to Ironwood’s U.S. lesinurad license. See Non-GAAP Financial Measures below.
- Cash Position
- Ironwood ended the first quarter of 2018 with about $194.4M of cash, cash equivalents and available-for-sale securities. Ironwood used about $30.9M of cash for operations during the first quarter of 2018.
(IRWD) price volatility for a month noted as 3.87% however its price volatility for a week documented as 4.72%. The corporation holds 146.13 million outstanding shares and its 137.31 million shares were floated in the market. The stock established a positive trend of 1.83% in last week and indicated rise of 8.85% in previous month.