Analyst Conference Summary

biotechnology

conference date: November 7, 2019 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2019 (third quarter, Q3)

Forward-looking statements

Overview: Clinical stage biotechnology company continues to develop its RNA based therapies.

Basic data (GAAP):

Revenue was $8.0 million, up sequentially from $5.7 million, and up from $1.5 million year-earlier.

Net income was negative $30.8 million, down sequentially from negative $23.8 million, and down from negative $19.0 million year-earlier.

Diluted EPS was negative $0.45, down sequentially from negative $0.35, and down from negative $0.35 year-earlier.

Guidance:

Dicerna believes that its current cash, cash-equivalents, and held-to-maturity investments will be sufficient to fund the execution of its current clinical and operating plan beyond 2021. Expects 2019 expenses to increase over 2018 expenses.

Conference Highlights:

Douglas Fambrough, CEO of Dicerna said "Dicerna has recently achieved two significant strategic objectives: dosing of patients in our PHYOX2 pivotal clinical trial and entering a collaboration agreement for the development of treatments for chronic hepatitis B virus infection with Roche, a global leader in the field" Has outgrown lab space, so relocating to a new headquarters.

Cash and equivalents balance ended at $313 million, down sequentially from $345 million. Will receive $200 million upon closing of Roche agreement.

Dicerna made a collaboration and licensing agreement with Roche to develop therapies for chronic hepatitis B virus (HBV) infection using GalXC RNAi platform technology, including DCR-HBVS, which is in Phase 1 clinical development. The agreement also includes the discovery and development of therapies targeting human genes associated with HBV infection, or additional targets within the HBV genome, using the technology platforms of both companies. Dicerna will receive $200 million up front plus up to $1.47 billion in potential milestone payments. Beieves should be competitive with therapies under deveopment. Early results are encouraging.

In early Q4 Dicerna initiated dosing in PHYOX2, a long-term, double blind, study of DCR-PHXC for the treatment of PH (primary hyperoxaluria) types 1 and 2. Should complete enrollment in 2020. Has Breakthrough Therapy Designation for DCR-PHXC for the treatment of primary hyperoxaluria type 1. PHYOX3 extension study continues; data in 1H 2020.

The multi-center Phase 1/2 trial of DCR-A1AT began Q3 2019, with first dosing expected in Q4 2019. The study will evaluate DCR-A1AT in adult healthy volunteers and patients with A1AT deficiency-associated liver disease. Dicerna in Q2 submitted a clinical trial application to the Swedish Medical Products Agency for DCR-A1AT for the treatment of patients with alpha-1 antitrypsin deficiency-associated (A1AT) liver disease.

Committed to fourth program, but will not announce target until ready to enter clinical phase.

Lilly and Alexion collaborations going well. But Boehringer dropped its first potential candidate.

Dicerna expects its overall R&D expense to continue to increase for the foreseeable future.

Expects to expand its internal pipeline in the coming quarters. Believe GalXC platform can be extended beyond the liver.

Operating expense of $40.7 million consisted of $30.1 million for R&D and $10.6 million for general and administrative expense. Loss from operations was $32.7 million. Interest income $1.9 million.

Q&A summary:

Potential target announcements from Lilly, Alexion? Milestones are on IND filing or first patient dose, would be low double digit millions.

Open label data timeline? We will share when we think it has become meaninful, which is before mid-year, but we don't have a conference in mind.

How do you see Roche's potential HBV combination agents? Decline to pick a favorite. But I know there are elements in that portfolio that have not been publically foreclosed. Believes a NUC will be a foundational element, but that may not be the Roche plan.

Dicerna expects to have non-hepatic programs of its own, but is still developing the platforms. In certain clinical types the knockdowns are good enough, but hopes to do better.

Are the major deals made for now? We are organizing our work into a Dicerna part and a collaborative part. We have a careful analysis of what goes into each bin. So the new cash addition will not change how we work. We see strong potential for additional collaborative activity.

Dicerna has not worked out the timing of revenue recognition for the $200 milestone payment expected. Will be recognized over the term of the collaboration.

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