Analyst Conference Summary

Biotechnology

Agenus
AGEN

conference date: May 9, 2019 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2019 (Q1, first quarter 2019)


Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $79.9 million, up sequentially from $1.1 million and up from $1.6 million year-earlier.

Net income was $17.4 million, up sequentially from negative $48.8 million, and up from negative $54.3 million year-earlier.

Earnings per share (EPS) were $0.14, up sequentially from negative $0.40, and down from negative $0.53 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "In the first quarter of this year, we have strengthened our balance sheet, accelerated enrollment in our BLA path trials, and started a new clinical trial with our second generation CTLA4."

Completed licensing deal with Gilead in Q1 2019, resulting in a $150 million up front payment. Later the IND was filed, resulting in a $7.5 million milestone payment. In the first quarter Agenus recognized revenue of $80 million which includes revenue from the Gilead transaction and non-cash royalties earned

BEST, biotech electronic security tokens, was launched in the quarter, to raise money tied to the PD-1 asset, AGEN2034. Offering may not complete until end of year. See Agenus Launches First Asset-Backed Digital-Security Offering.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections, exceeding $1.3 billion. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. A $40 million milestone payment to Agenus is possible if the milestone is achieved.

A large-scale trial with GSK's Mosquirix vaccine, containing QS-21, against malaria, began in Africa

Agenus continued a Phase 2 combination trial of AGEN1884 with Keytruda for IL NSCLC with over 50% PD-L1 expression. Expanding targets and combinations as data has been good.

The AGEN1884 and AGEN2034 phase 2 trial combining these drugs to treat cervical cancer continued. Dicussions with FDA indicate a BLA for for AGEN2034 and AGEN1884 could be filed as early as 2020. 1884 and 2034 are in 3 active clinical trials including the two combined.

Next-Gen CTLA-4, AGEN1181, began enrollment in 2019. Could be a best-in-class combination agent. This is designed to delete T-regs and increase priming.

First-in-class bispecific, AGEN1223, should enter the clinic in 2019. Believes the new antibodies can differentiate Agenus from competitors.

AutoSynVax vaccine trials are being planned in combination with QS-21 and 1884.

Bruno Lucidi, CEO of Agentus, gave an update on the cell therapy products (CAR-T and related). Hopes to have its first IND in 2019. Going beyond current approaches. Believes has capabilities to target solid tumors. Working on collaboration or private investment in the subsidiary. Has a platform to develope TCR and CAR-T therapies. Has a proprietary allogenic platform and PDT platform. Is in an advanced state of discussions for a private round of funding.

Gilead filed an IND for GS-1423, which was AGEN1423 and generated $90 million in an upfront payment and $7.5 million for the IND. In addition Gilead invested $30 million in Agenus equity.

In total Agenus hopes to file 3 INDS in 2019.

Prophage for newly diagnosed GBM (glioblastoma, a brain cancer) program continues.

Incyte-partnered checkpoint inhibitors from Agenus continue to be advanced in preclinical or clinical trials. INCAGN1876 (GITR) completed dose escalation; INCAGN1949 (OX40) also completed dose escalation. For both development is expected to focus on combination therapy. INCAGN2385 (LAG-3) and INCAGN2390 (TIM-3)are in Phase 1 trials.

A portfolio of undisclosed bispecific checkpoint modulators is being advanced in the lab. Neoantigen vaccines continue to be developed. Animal models have shown synergy between CPMs and vaccines. Agenus is identifying mutated proteins from cancers that could serve as a basis for vaccines. Some new molecules may be partnered. Expects meaningful clinical data this year.

Cost of sales was $0 million. Research and development expense was $ million. General and administrative expense was $ million. Other expense of $ million.

Cash and equivalents balance ended at $158 million, up sequentially from $53 million. No debt, but has received advances on vaccine royalties, which is a liability. In Q1 2019 received $150 million payment from Gilead plus a $7.5 million milestone.

Making greater efforts to inform investors of the company's value.

Q&A summary:

Next gen CTLA4 trial details? Recently started the dose escalation trial. At the end of each dose we expect to introduce a combination. By end of year we should have some early data.

Agentus financing? A private round should complete in the next few months. We may do a public offering some time next year.

[no further questions. Presentation was likely longer than analysts could allocate on such a busy reporting day.

Agenus web site

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Disclaimer: My analyst call summaries may include both our 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. This is journalism, not investment advice.

Copyright 2019 William P. Meyers