Analyst Conference Summary

Biotechnology

conference date: August 9, 2018 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2018 (Q2, second quarter 2018)

Forward-looking statements

Overview: Continues pipeline development and discussions with possible partners. Revenue remains very lumpy.

Basic data (GAAP):

Revenue was $2.0 million, down 57% sequentially from $4.6 million, and down 69% from $6.5 million year-earlier.

Net income was negative $11.3 million, down sequentially from negative $9.4 million, and down from $0.5 million year-earlier.

EPS was negative $0.08, down sequentially from negative $0.06, and down from $0.00 year-earlier.

Guidance:

Cash from Chiesi means funding through commercialization of PRX-102.

Conference Highlights:

Moshe Manor, Protalix’s CEO, said "This has been a fantastic quarter for the company highlighted by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months. Additionally, we believe that the recent draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies could significantly benefit the regulatory path forward for PRX-102."

Revenue drop was due to lower sales to Pfizer and Brazil. Revenue is generated by taliglucerase alfa sales.

For PRX-102, Pegunigalsidase alfa, for Fabry disease Phase 3 studies continued enrollment, with completion expected in 2018. Blood sample data was released in May. 12-month interim data analysis expected in 1H 2019 and complete data in 2H 2019. It is a 24 month study. [See PRX-102 press release for details] Ex-U.S. rights were sold to Chiesi Farmaceutici S.p.A, with Protalix to receive $25 million upfront, an additional up to $20 million in development costs and an additional up to $650 million in potential regulatory and commercial milestone payments. If commercialized Protalix to receive tiered royalties ranging from 15% to 40% on net sales. PRX-102 received Fast Track designation in the U.S. and Orphan Drug designation in the EU. In July the FDA issued a draft guidelines on enzyme replacement therapies that might help the chances of PRX-102 for approval.

For PRX-110, Alidornase alfa, for Cystic Fibrosis, the foundation grant is still under review. In active discussions with potential partners.

OPRX-106, an oral anti-TNF for ulcerative colitis Phase 2 top line results were positive. 67% of patients experienced a clinical response. Partnership discussions have begun. Data was presented at a meeting in June.

An oral version of Humira is being worked on, no timeline for moving to clinical trials.

Cash balance ended at $28.3 million, down sequentially from $41.3 million. After the quarter ended exchanged 4.50% convertible notes for a combination of shares and cash, and effectively discharged the remainder of the 4.50% notes. But there are still the 2021 notes.

Believes has funding into 2020 using present cash only. RandD expense will be reduced as Chiesi assumes responsibility.

Cost of revenue was $5.1 million, leaving gross profit of $1.5 million. R&D (net of grants) expense $13.7 million. SG&A $4.7 million. Leaving an operating loss of $16.9 million. Financial expense $4.0 million, financial income $0.2 million.

Q&A:

We continue discussions with potential partners on our other drugs.

Moving other candidates forward? We are evaluating in the second half of year, we don't want to not have enough resource for PRX-102.

Brazil revenue? $2.6 million from Brazil in first half.

Remaining 2021 convertible notes? Chiesi funds should be sufficient to cover that.

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