Dew, have you listened to the call yet? Clearly September is going to be a very busy month for IDIX with the reporting of data from the IDX184 Phase 2a study, the IDX320 Phase 1/2 3-day study, and the 184/320 Phase 1 2-week PK study. Management guided for the reporting of all three data sets in September.
I am very curious about the caller asking around the 32-minute mark of the call about any side effects seen at higher dosing cohorts in the 184 Phase 2a study compared to lower dosing cohorts. Management states that they don't believe there are any side effects that appear to be dose-related, but there is also mention that there were "no further creatinine elevations since the 100mg cohort in any of the subsequent cohorts." (This is right at about the 32:20 mark of the call.) Can't one infer from this that there were creatinine elevations then in some cohort. The prior Phase 2a PR for 184 (#msg-49096739 ) does not speak to any side effect concerns. Of course, even if there were creatinine elevation issues, it would not necessarily be due to 184 and could be due solely to PegIFN/RBV. Anyways, just trying to clarify management comments here. TIA for your help.
At the $13.7 average quarterly burn rate during the four most recent quarters, the 6/30/10 balance of $51.0M is sufficient to fund operations for 3.7 quarters without additional funding. If a partnership deal is struck for IDX184 (with or without IDX320) during 2010, the upfront cash from the deal will presumably make IDIX’s liquidity moot.
Operating cash burn and quarter-ending cash balance for the past ten quarters were as follows (all figures in $M):
Idenix Pharmaceuticals Reports Third Quarter and Nine Month 2010 Financial Results
CAMBRIDGE, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the third quarter and nine months ended September 30, 2010. At September 30, 2010, Idenix's cash and cash equivalents totaled $37.0 million.
Third Quarter 2010 Financial Results
For the third quarter ended September 30, 2010, Idenix reported total revenues of $3.8 million, compared to total revenues of $3.1 million in the third quarter of 2009. The company reported a net loss of $12.9 million, or a loss of $0.18 per basic and diluted share, for the third quarter ended September 30, 2010, compared to a net loss of $ $11.7 million, or a loss of $0.18 per basic and diluted share for the third quarter ended September 30, 2009.
For the nine months ended September 30, 2010, Idenix reported total revenues of $7.8 million, compared to total revenues of $9.6 million for the nine months ended September 30, 2009. The company reported a net loss of $45.4 million, or a loss of $0.65 per basic and diluted share, for the nine months ended September 30, 2010, compared to a net loss of $40.9 million, or a loss of $0.68 per basic and diluted share, for the nine months ended September 30, 2009.
2010 Financial Guidance
The company expects that its current cash and cash equivalents, the anticipated royalty payments associated with product sales of Tyzeka®/Sebivo® (telbivudine) and its ability and intent to manage expenditures will be sufficient to satisfy our cash needs for at least the next 12 months. This guidance assumes no additional milestone payments, license fees, reimbursement for development programs and no financing activities.
Regulatory Update
In September 2010, the U.S. Food and Drug Administration (FDA) placed two of our HCV drug candidates, IDX184 and IDX320, on clinical hold following a 14-day drug-drug interaction study of a combination of IDX184 and IDX320 in healthy volunteers. Idenix is working with the FDA to determine the next steps in the development of these drug candidates.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with chronic hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.