Investor Relations (IR) Questions: Idenix Pharmaceuticals
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Information updated: June 2013
BACKGROUND
Idenix is primarily focused on the treatment of hepatitis C (HCV). The Company has no products on the market at this time. Idenix did successfully co-develop and bring Tyzeka®/Sebivo® to market. The company received royalty payments from the sale of Tyzeka®/Sebivo® up until July, 2012. At this time Idenix does not have any products on the market that generate income for the Company. However, Idenix does have a healthy amount of cash.
In addition to the Company’s ongoing studies, it is currently a party to a patent dispute with Gilead. In the first phase of the dispute's resolution, the United States Patent and Trademark Office Patent Trial and Appeal Board (USPTO) has identified Idenix as the “junior” party and Gilead has been identified as the “senior” party. The Company has reported that the second phase is expected to commence in the second quarter of 2013. This phase will determine the prevailing party by identifying who was first to invent. The Company believes that the pending ruling by the USPTO will not impact the catalysts/programs itemized below.
-1- When is the last time IDIX raised cash through an offering (diluted)?
-a- On August 2, 2012 the Company priced the sale of 22,000,000 shares at $8.00 per share. Underwriters were given a 30 day option to purchase up to 3,300,000 additional shares to cover over-allotments.
-2- How much cash (not cash equivalents) does IDIX have?
-b- On March 31, 2013, the company reported cash and equivalents at $205,297,000.
-3- What and approximately when is the next known catalyst?
-c- On May 30, 2013 the Company announced the initiation of a Phase II HELIX-1 trial collaboration with Janssen Pharmaceuticals. The study is evaluating Samatasvir (IDX719) and Simeprevir (TMC435) for the Treatment of Hepatitis C Virus. “A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to initiate in the second half of 2013.”
-d- In February 2013, the Company discontinued two development programs for the treatment of viral disease, IDX184 and IDX19368. This decision was made after the FDA put “IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094.” However, the Company is “...completing IND-enabling studies for a uridine nucleotide analog, which is in a sub-class of nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and BMS-986094. The Company expects to file an IND for this compound in the first half of 2013.
-4- What is IDIX's quarterly cash burn?
-e- Total operating expenses for the first 3 months of 2013 were $31,875,000 compared to $24,537,000 for the same period in 2012.
-f- Total Operating Expenses by Year
2012.......... $105,044,000
2011.......... $ 60,359,000
2010.......... $ 72,948,000
2009.......... $ 67,050,000
-5-Does IDIX have an existing line of credit and if so how much can they draw against it?
After reviewing IDIX's public filings and press releases, I was unable to find anything regarding an existing credit facility. I don't believe they have one but for confirmation, I recommend contacting the Company directly.
A complete archive of #IRQ research and IR responses can be found athttp://www.biotechduediligence.com/ir-questions.html.
RESOURCES:
Background: Information gathered from IDIX's public filings, press releases, and website, http://www.idenix.com/.
-a- IDIX PR 08/02/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=697629
-b- IDIX Page 3, 10-Q for the period ending March 31, 2013 http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-187596&CIK=1093649
-c- IDIX PR 05/30/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=768078
-d- IDIX PR 02/04/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=737733
-e- IDIX Page 4, 10-Q for the period ending March 31, 2013 http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-187596&CIK=1093649
-f- IDIX Page 52, 10-K for the fiscal year ended December 31, 2012http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-74136&CIK=1093649
BACKGROUND
Idenix is primarily focused on the treatment of hepatitis C (HCV). The Company has no products on the market at this time. Idenix did successfully co-develop and bring Tyzeka®/Sebivo® to market. The company received royalty payments from the sale of Tyzeka®/Sebivo® up until July, 2012. At this time Idenix does not have any products on the market that generate income for the Company. However, Idenix does have a healthy amount of cash.
In addition to the Company’s ongoing studies, it is currently a party to a patent dispute with Gilead. In the first phase of the dispute's resolution, the United States Patent and Trademark Office Patent Trial and Appeal Board (USPTO) has identified Idenix as the “junior” party and Gilead has been identified as the “senior” party. The Company has reported that the second phase is expected to commence in the second quarter of 2013. This phase will determine the prevailing party by identifying who was first to invent. The Company believes that the pending ruling by the USPTO will not impact the catalysts/programs itemized below.
-1- When is the last time IDIX raised cash through an offering (diluted)?
-a- On August 2, 2012 the Company priced the sale of 22,000,000 shares at $8.00 per share. Underwriters were given a 30 day option to purchase up to 3,300,000 additional shares to cover over-allotments.
-2- How much cash (not cash equivalents) does IDIX have?
-b- On March 31, 2013, the company reported cash and equivalents at $205,297,000.
-3- What and approximately when is the next known catalyst?
-c- On May 30, 2013 the Company announced the initiation of a Phase II HELIX-1 trial collaboration with Janssen Pharmaceuticals. The study is evaluating Samatasvir (IDX719) and Simeprevir (TMC435) for the Treatment of Hepatitis C Virus. “A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to initiate in the second half of 2013.”
-d- In February 2013, the Company discontinued two development programs for the treatment of viral disease, IDX184 and IDX19368. This decision was made after the FDA put “IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094.” However, the Company is “...completing IND-enabling studies for a uridine nucleotide analog, which is in a sub-class of nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and BMS-986094. The Company expects to file an IND for this compound in the first half of 2013.
-4- What is IDIX's quarterly cash burn?
-e- Total operating expenses for the first 3 months of 2013 were $31,875,000 compared to $24,537,000 for the same period in 2012.
-f- Total Operating Expenses by Year
2012.......... $105,044,000
2011.......... $ 60,359,000
2010.......... $ 72,948,000
2009.......... $ 67,050,000
-5-Does IDIX have an existing line of credit and if so how much can they draw against it?
After reviewing IDIX's public filings and press releases, I was unable to find anything regarding an existing credit facility. I don't believe they have one but for confirmation, I recommend contacting the Company directly.
A complete archive of #IRQ research and IR responses can be found athttp://www.biotechduediligence.com/ir-questions.html.
RESOURCES:
Background: Information gathered from IDIX's public filings, press releases, and website, http://www.idenix.com/.
-a- IDIX PR 08/02/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=697629
-b- IDIX Page 3, 10-Q for the period ending March 31, 2013 http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-187596&CIK=1093649
-c- IDIX PR 05/30/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=768078
-d- IDIX PR 02/04/2013 http://ir.idenix.com/releasedetail.cfm?ReleaseID=737733
-e- IDIX Page 4, 10-Q for the period ending March 31, 2013 http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-187596&CIK=1093649
-f- IDIX Page 52, 10-K for the fiscal year ended December 31, 2012http://ir.idenix.com/secfiling.cfm?filingID=1193125-13-74136&CIK=1093649