 |
|
|
|
|
|
|
|
 |
|
||||||
 |
 |
 |
 |
 |
 |
 |
|
Analyst Conference Summary
Biotechnology
Tetraphase Pharmaceuticals
TTPH
No conference was held. Data from press release
date: May 3, 2018
for quarter ending: March 31, 2018 (first quarter 2018)
Overview: Could get first FDA approval, eravacycline for cIAI by Q3 2018
Basic data (GAAP):
Revenue was $1.9 million, up from $1.5 million year-earlier.
Net income was negative $21.6 million, up from negative $29.5 million year-earlier.
Diluted EPS was negative $0.42, up from negative $0.79 year-earlier.
Guidance:
none
Conference Highlights:
Received a Prescription User Fee Act (PDUFA) goal date of August 28, 2018 for IV eravacycline for the treatment of cIAI (complicated intra-abdominal infections). The NDA submission includes data from two phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates. Both studies demonstrated statistical non-inferiority of eravacycline to widely used comparators – ertapenem and meropenem – for the primary efficacy endpoint of clinical response at the test-of-cure visit.
Guy Macdonald, Tetraphase CEO, said "we revised our eravacycline strategy to focus primarily on the commercialization of the IV formulation of the drug in complicated intra-abdominal infections (cIAI)." Making preparations to bring to market if the FDA approves. An EU approval could come in 2019.
Also main a deal to license the drug in China with Everest Medicines.
But eravacycline did not work for cUTI (complicated urinary track infections), so that program has been discontinued.
Cash and equivalents ended at $117.7 million. No debt. That should fund operations through the first half of 2019.
Further down the pipeline, TP-271 and TP-6076 should complete Phase 1 dosing studies by the end of the year.
Operating expense was $23.8 million, consisting of R&D $18.1 million and G&A $5.7 million. Loss from operations $21.9 million. Other income $0.4 million.
Q&A:
none, no conference held
OpenIcon Analyst Conference Summaries Main Page
More Analyst Conference Pages:
| AGEN |
| AGIO |
| ALNY |
| ALXN |
| AMAT |
| AMD |
| AMGN |
| BIIB |
| CLDX |
| CELG |
| EPZM |
| GILD |
| GLYC |
| INO |
| INTC |
| ISRG |
| MACK |
| MCHP |
| MYL. |
| NVDA |
| PLX |
| REGN |
| SGEN |
| XLNX |
| XLRN |
Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.
Copyright 2018 William P. Meyers