Investor Relations (IR) Questions: Ironwood Pharmaceuticals $IRWD
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Answers compiled: May 2013
BACKGROUND
Ironwood Pharmaceuticals' lead product/candidate is linaclotide. Linaclotide is currently approved for two indications, 1) the treatment of both irritable bowl syndrome with constipation (IBS-C) and 2) chronic idiopathic constipation (CIC). Linaclotide is registered in the United States under the trade name LINZESS and in the European Union as Constella. The Company has partnered with Almirall S.A in the European Union and with Forest in the United States to market linaclotide. The Company also has ongoing clinical trials aimed at securing linaclotide's approval in additional markets. Ironwood is partnered with AstraZeneca in China and Astellas in Japan.
The Company is actively advancing additional early stage studies for other indications such as its collaboration with Bionomics Ltd focused on CNS disease. Other areas of study being explored by the Company include treatment for anxiety and cardiovascular disease. These studies may eventually become important catalysts for both the Company and the investor. However, at the present time, IT'S ALL ABOUT LINACLOTIDE!
-1- When is the last time IRWD raised cash through an offering (diluted)?
-a- On May 20, 2013 the Company announced a public offering of 10,500,000 shares of its Class A common stock. Underwriters will have a 30 day option to purchase an additional 1,575,000 shares. The Company has not announced the pricing of the offering yet.
-2- How much cash (not cash equivalents) does IRWD have?
-b- At the end of 1Q 2013 the Company had approximately $242 million of cash, cash equivalents and available-for-sale securities.
-c- On 03/31/2013 “cash and cash equivalents” were $105,302,000 and “available-for-sale securities” were $136,727,000.
-3- What and approximately when is the next known catalyst?
-b- The Company expects to report Phase IIIb data on the effect of LINZESS on abdominal symptoms in patients with chronic idiopathic constipation in the second half of 2013.
-b- In the next 12 months, Ironwood and Forest expect to initiate new studies involving linaclotide to discover additional indications for LINZESS both as a stand alone drug and in combination with other products.
-b- “Ironwood's European partner, Almirall S.A., intends to initiate launches of Constella in the U.K. and Germany during the second quarter of 2013.”
-b- Astellas, Ironwood's partner in Japan is expected to complete a Phase II clinical trial of linaclotide
in patients with IBS-C during the second half of 2013.
-b- Ironwood and it's partner in China, AstraZeneca expect to initate a Phase III clinical trial of linaclotide in patients with IBS-C in the second half of 2013.
-4- What is IRWD's quarterly cash burn?
-b- In the first quarter of 2013 Ironwood spent approximately $93 million.
-d- Total Cost and Expenses:
2012........ $223,007,000
2011........ $132,013,000
2010........ $104,623,000
2009........ $ 95,137,000
-5- Does IRWD have an existing line of credit and if so how much can they draw against it?
-e- Ironwood does not have an existing credit facility. However, the Compnay has issued debt securities. As of March 31, 2013, the Company's total indebtedness was reported at approximately $175 million.
A complete archive of this and additional #IRQ research and IR responses can be found at http://www.biotechduediligence.com/ir-questions.html.
RESOURCES:
Background: IRWD website: http://www.ironwoodpharma.com/index.php
-a- IRWD PR 05/20/2013 http://investor.ironwoodpharma.com/releasedetail.cfm?ReleaseID=766059
-b- IRWD PR 04/23/2013 http://investor.ironwoodpharma.com/releasedetail.cfm?ReleaseID=758361
-c- Page 5, IRWD 10-Q for the period ending 03/31/2013 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1104659-13-31578
-d- Page 44, IRWD 10-K for the year ended December 31, 2012 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1047469-13-1388
-e- Page 43, IRWD 10-Q for the period ending 03/31/2013 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1104659-13-31578
BACKGROUND
Ironwood Pharmaceuticals' lead product/candidate is linaclotide. Linaclotide is currently approved for two indications, 1) the treatment of both irritable bowl syndrome with constipation (IBS-C) and 2) chronic idiopathic constipation (CIC). Linaclotide is registered in the United States under the trade name LINZESS and in the European Union as Constella. The Company has partnered with Almirall S.A in the European Union and with Forest in the United States to market linaclotide. The Company also has ongoing clinical trials aimed at securing linaclotide's approval in additional markets. Ironwood is partnered with AstraZeneca in China and Astellas in Japan.
The Company is actively advancing additional early stage studies for other indications such as its collaboration with Bionomics Ltd focused on CNS disease. Other areas of study being explored by the Company include treatment for anxiety and cardiovascular disease. These studies may eventually become important catalysts for both the Company and the investor. However, at the present time, IT'S ALL ABOUT LINACLOTIDE!
-1- When is the last time IRWD raised cash through an offering (diluted)?
-a- On May 20, 2013 the Company announced a public offering of 10,500,000 shares of its Class A common stock. Underwriters will have a 30 day option to purchase an additional 1,575,000 shares. The Company has not announced the pricing of the offering yet.
-2- How much cash (not cash equivalents) does IRWD have?
-b- At the end of 1Q 2013 the Company had approximately $242 million of cash, cash equivalents and available-for-sale securities.
-c- On 03/31/2013 “cash and cash equivalents” were $105,302,000 and “available-for-sale securities” were $136,727,000.
-3- What and approximately when is the next known catalyst?
-b- The Company expects to report Phase IIIb data on the effect of LINZESS on abdominal symptoms in patients with chronic idiopathic constipation in the second half of 2013.
-b- In the next 12 months, Ironwood and Forest expect to initiate new studies involving linaclotide to discover additional indications for LINZESS both as a stand alone drug and in combination with other products.
-b- “Ironwood's European partner, Almirall S.A., intends to initiate launches of Constella in the U.K. and Germany during the second quarter of 2013.”
-b- Astellas, Ironwood's partner in Japan is expected to complete a Phase II clinical trial of linaclotide
in patients with IBS-C during the second half of 2013.
-b- Ironwood and it's partner in China, AstraZeneca expect to initate a Phase III clinical trial of linaclotide in patients with IBS-C in the second half of 2013.
-4- What is IRWD's quarterly cash burn?
-b- In the first quarter of 2013 Ironwood spent approximately $93 million.
-d- Total Cost and Expenses:
2012........ $223,007,000
2011........ $132,013,000
2010........ $104,623,000
2009........ $ 95,137,000
-5- Does IRWD have an existing line of credit and if so how much can they draw against it?
-e- Ironwood does not have an existing credit facility. However, the Compnay has issued debt securities. As of March 31, 2013, the Company's total indebtedness was reported at approximately $175 million.
A complete archive of this and additional #IRQ research and IR responses can be found at http://www.biotechduediligence.com/ir-questions.html.
RESOURCES:
Background: IRWD website: http://www.ironwoodpharma.com/index.php
-a- IRWD PR 05/20/2013 http://investor.ironwoodpharma.com/releasedetail.cfm?ReleaseID=766059
-b- IRWD PR 04/23/2013 http://investor.ironwoodpharma.com/releasedetail.cfm?ReleaseID=758361
-c- Page 5, IRWD 10-Q for the period ending 03/31/2013 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1104659-13-31578
-d- Page 44, IRWD 10-K for the year ended December 31, 2012 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1047469-13-1388
-e- Page 43, IRWD 10-Q for the period ending 03/31/2013 http://investor.ironwoodpharma.com/secfiling.cfm?filingID=1104659-13-31578