Full Press Release Details
Pharmaceuticals Reports Second Quarter 2020 Results; Delivered GAAP Net
of $25 Million and Adjusted EBITDA of $33 Million
Grew LINZESS (Iinaclotide) total prescription demand by 9% year-over-year; new-to-brand prescription demand
grew >15% in June 2020 compared to March 2020 -
Made important updates designed to strengthen IW-3718 Phase III program; FDA indicated that long-term safety study for
IW-3718 is not required for an NDA submission -
Reinstating full year 2020 total revenue and LINZESS net sales growth guidance; reiterating adjusted EBITDA guidance -
Mass., August 6, 2020 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today provided an update on its second quarter 2020 results and recent business performance, as well as an
update related to the impact of the COVID-19 pandemic on its business.
execution resulted in another solid quarter, highlighting the fundamental strength and resiliency of our business as we
continue to advance our mission of advancing GI diseases and redefining the standard of care for millions of GI patients,
despite the challenges posed by the COVID-19 pandemic," said Mark Mallon, chief executive officer of Ironwood.
"We are disappointed by the Phase II results for MD-7246; however, our strategy remains clear and we believe we are
well-positioned for long-term growth, evidenced by continued LINZESS performance, the updates we made designed to strengthen
our IW-3718 Phase III program, and our fifth consecutive profitable quarter."
COVID-19 Business Impact
The impact of the COVID-19 pandemic
continues to be far-reaching and unpredictable in the U.S. and around the world. Ironwood is taking important actions designed
to help mitigate the impacts of the COVID-19 pandemic on its business and is following applicable federal, state and local health
Second Quarter 2020 Financial
(in thousands, except for
| 2Q 2020 | 2Q 2019 | |||||||
| Total revenues | $ | 89,432 | $ | 102,215 | ||||
| Total costs and expenses | 56,719 | 80,638 | ||||||
| GAAP net income from continuing operations | 25,204 | 12,283 | ||||||
| GAAP net income | 25,204 | 12,283 | ||||||
| GAAP net income per share - basic and diluted | 0.16 | 0.08 | ||||||
| Adjusted EBITDA | 33,353 | 25,645 | ||||||
| Non-GAAP net income | 25,671 | 16,032 | ||||||
| Non-GAAP net income per share | 0.16 | 0.10 |
Second Quarter 2020 Corporate
| U.S. LINZESS Full Brand Collaboration 1 (in thousands, except for percentages) | Three Months Ended June 30, | |||||||
| 2020 | 2019 | |||||||
| LINZESS U.S. net sales as reported by AbbVie | $ | 218,945 | $ | 207,716 | ||||
| AbbVie & Ironwood commercial costs, expenses and other discounts | 53,812 | 76,987 | ||||||
| Commercial margin | 75 | % | 63 | % | ||||
| AbbVie & Ironwood R&D Expenses | 13,417 | 14,474 | ||||||
| Total net profit on sales of LINZESS | $ | 151,716 | $ | 116,255 | ||||
| Full brand margin | 69 | % | 56 | % |
Global Collaborations and
U.S. Promotional Partnerships
Second Quarter Financial Results
| 2020 Guidance | |
| LINZESS net sales growth | Mid-single digit % increase |
| Total Revenue | $360 - $380 million |
| Adjusted EBITDA 1 | >$105 million |
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 net income (loss) from continuing operations.
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, and separation-related
expenses from non-GAAP net income (loss), if any. These adjustments, as applicable, are reflected in the non-GAAP net income (loss)
in the second 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, and separation expenses from GAAP net income (loss) from continuing operations. 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 net income (loss) from continuing operations
on a GAAP basis, please refer to the tables at the end of this press release.
Ironwood does not provide
guidance on GAAP net income (loss) from continuing operations or a reconciliation of expected adjusted EBITDA to expected
GAAP net income (loss) from continuing operations 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 net income (loss) from continuing operations for the
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m.
Eastern Time on Thursday, August 6, 2020 to discuss its second quarter 2020 results and recent business activities. Individuals
interested in participating in the call should dial (866) 324- 3683 (U.S. and Canada) or (509) 844-0959 (international) using conference
ID number 6183913. 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 11:30 a.m. Eastern Time on August 6, 2020 running through
11:59 p.m. Eastern Time on August 20, 2020. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-4306 (international)
using conference ID number 6183913. 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). We are also advancing IW-3718, a gastric retentive formulation of a bile acid
sequestrant being developed for the potential treatment of refractory gastroesophageal reflux disease. IW-3718 is first-in-category
product candidate currently in Phase III clinical trials.
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 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.
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 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 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 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