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Ironwood Pharmaceuticals Reports Strong Third Quarter 2020 Results and Increases Full Year 2020 Financial Guidance - U.S. LINZESS (linaclotide) net sales increased 10% year-over-year to $241 million

Key Takeaway: Pharmaceuticals Reports Strong Third Quarter 2020 Results and Increases Full Year 2020 Financial Guidance U.S. LINZESS (linaclotide) net sales increased 10% year-over-year to $241 million, as reported by AbbVie Inc. (AbbVie) - U.S. LINZESS collaboration revenue to Ironwood in

Full Press Release Details

Pharmaceuticals Reports Strong Third Quarter 2020 Results and
Increases Full Year 2020 Financial Guidance
U.S. LINZESS (linaclotide) net sales increased 10% year-over-year to $241 million,
as reported by AbbVie Inc. (AbbVie) -
U.S. LINZESS collaboration revenue to Ironwood increased 18% year-over-year to $100 million, resulting in 3Q 2020 total Ironwood
revenue of $103 million -
3Q 2020 GAAP net income was $34 million and adjusted EBITDA was $47 million -
Expect total cost savings of approximately $95 million, excluding anticipated one-time costs, relating to discontinuation of
IW-3718 and planned workforce reduction -
BOSTON, Mass., November 5, 2020 - Ironwood
Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today provided an update on its third quarter
2020 results and recent business performance.
financial performance this quarter was bolstered by continued demand for our market leading product LINZESS, which delivered
10% growth in net sales year-over-year, and another quarter of profitability and positive cash flow for Ironwood," said
Mark Mallon, chief executive officer of Ironwood. "While our pipeline experienced disappointing setbacks, we are
confident that under the seasoned leadership of our talented, GI-experienced team, we are positioned well to execute against
our strategic priorities. Through our focused efforts, we seek to unlock meaningful shareholder value as we progress our
mission of advancing GI medicines and redefining the standard of care for GI patients."
Quarter 2020 Financial Highlights1
(in thousands, except for per share amounts)
3Q 2020 3Q 2019
Total revenues $103,468 $131,167
Total costs and expenses 57,852 65,280
GAAP income from continuing operations, net of income taxes 34,423 20,648
GAAP net income 34,423 20,648
GAAP net income per share - basic 0.22 0.13
GAAP net income per share -diluted 0.21 0.13
Adjusted EBITDA 47,437 75,659
Non-GAAP net income 38,271 62,921
Non-GAAP net income per share - basic 0.24 0.40
Non-GAAP net income per share - diluted 0.23 0.40
Quarter 2020 Corporate Highlights
U.S. LINZESS Full Brand Collaboration 1 (in thousands, except for percentages) Three Months Ended September 30,
2020 2019
LINZESS U.S. net sales as reported by AbbVie $241,124 $220,037
AbbVie & Ironwood commercial costs, expenses and other discounts 52,939 74,519
Commercial margin 78% 66%
AbbVie & Ironwood R&D Expenses 11,207 16,436
Total net profit on sales of LINZESS $176,978 $129,082
Full brand margin 73% 59%
Global Collaborations and U.S. Promotional Partnerships
Third Quarter Financial Results
Prior 2020 Guidance Revised 2020 Guidance
LINZESS net sales growth Mid-single digit % increase High-single digit % increase
Total Revenue $360 - $380 million $370 - $385 million
Adjusted EBITDA 1 >$105 million >$130 million
1 Adjusted EBITDA is calculated by subtracting
net interest expense, taxes, depreciation, amortization, mark-to-market adjustments on derivatives related to Ironwood's
2022 Convertible Notes, restructuring expenses, separation expenses, and loss on extinguishment of debt from GAAP income from continuing
operations, net of income taxes.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income (loss) and non-GAAP net
income (loss) per share to exclude the impact of net gains and losses on derivatives related to our 2022 Convertible Notes that
are required to be marked-to-market. Ironwood also excludes restructuring, separation-related expenses, and loss on extinguishment
of debt from non-GAAP net income (loss), if any. These adjustments, as applicable, are reflected in the non-GAAP net income (loss)
in the third quarter 2020 presented in this press release. Non-GAAP adjustments are further detailed below:
Ironwood also presents adjusted EBITDA, a non-GAAP measure,
as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting net interest expense, taxes, depreciation,
amortization, mark-to-market adjustments on derivatives related to Ironwood's 2022 Convertible Notes, restructuring expenses,
separation expenses and loss on extinguishment of debt from GAAP income from continuing operations, net of income taxes. The adjustments
are made on a similar basis as described above related to non-GAAP net income (loss), as applicable.
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 non-GAAP net income
(loss) and non-GAAP net income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, and
for a reconciliation of adjusted EBITDA to income from continuing operations, net of income taxes on a GAAP basis, please refer
to the tables at the end of this press release.
Ironwood does not provide guidance on GAAP income from continuing
operations, net of income taxes or a reconciliation of expected adjusted EBITDA to expected GAAP income from continuing operations,
net of income taxes because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP adjustments
used to calculate adjusted EBITDA including, without limitation, the mark-to-market adjustments on the derivatives related to its
2022 Convertible Notes. These adjustments are uncertain, depend on various factors and could have a material impact on GAAP
income from continuing operations, net of income taxes for the guidance period.
Conference Call Information
Ironwood will host a conference call and webcast at 4:30 p.m. Eastern
Time on Thursday, November 5, 2020 to discuss its third quarter 2020 results and recent business activities. Individuals interested
in participating in the call should dial (833) 350-1432 (U.S. and Canada) or (647) 689-6932 (international) using conference ID
number 2794527. 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 November 5, 2020
running through 11:59 p.m. Eastern Time on November 19, 2020. To listen to the replay, dial (800) 585-8367 (U.S. and
Canada) or (416) 621-4642 (international) using conference ID number 2794527. 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 GI-focused healthcare
company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and
are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation
(IBS-C) or chronic idiopathic constipation (CIC).
Ironwood was founded in 1998 and is headquartered in Boston,
Mass. For more information, please visit our website at 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)
prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic
constipation (CIC), based on IQVIA data.
LINZESS is a once-daily
capsule that helps relieve the overall abdominal symptoms (bloating, discomfort and 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 guanylate
cyclase-C (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 of 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 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 AbbVie co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie 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 or CIC. Ironwood also has partnered with AstraZeneca for development
and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories
Important Safety Information
Last updated: Nov 5, 2020