Analyst Conference Summary

Biotechnology

No conference was held. Data from press release

date: August 2, 2018
for quarter ending: June 30, 2018 (second quarter 2018)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $11.6 million, up sequentially from $1.9 million, and up from $1.6 million year-earlier.

Net income was negative $9.5 million, up sequentially from negative $21.6 million, and up from negative $31.8 million year-earlier.

Diluted EPS was negative $0.18, sequentially from negative $0.42, and up from negative $0.83 year-earlier.

Guidance:

Expects to begin commercial sales in Q4 2018.

Conference Highlights:

Has 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 "In the second quarter of 2018, we moved closer to achieving our goal to bring XeravaTM (eravacycline) to market on a global level as an important new antibiotic for patients with serious, often life-threating, complicated intra-abdominal infections (cIAI). We recently announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Xerava in cIAI, and we expect a final decision on marketing authorization from the European Commission (EC) later this year. In the U.S., we are eagerly looking forward to a decision on our PDUFA (Prescription Drug User Fee Act) date of August 28, 2018 and we are actively preparing for the potential commercial launch of Xerava in the fourth quarter."

Also made a deal to license the drug in China with Everest Medicines and received a $2.5 million milestone payment.

But eravacycline did not work for cUTI (complicated urinary track infections), so that program was discontinued in Q1.

Cash and equivalents ended at $111.2 million, down sequentially from $117.7 million. No debt. That should fund operations through the third quarter 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 $21.6 million, consisting of R&D $14.4 million and G&A $7.2 million. Loss from operations $10.0 million. Other income $0.4 million.

Q&A:

none, no conference held

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