Image source: Juno Therapeutics.
2016 has been pretty much a disaster for Juno Therapeutics (NASDAQ: JUNO) so far. Shares of the biotech were down nearly 45% year to date in early February. While Juno's stock regained some of those losses, shares were still down 20% at the end of the month.
Juno announced its fourth-quarter results on Monday after the market closed. Were they enough to turn things around? Here are the highlights.
Juno Therapeutics results: The raw numbers
|
Q4 2015 Actuals |
Q4 2014 Actuals |
Growth (YOY) | |
|---|---|---|---|
|
Sales |
$4.15 million |
--- | N/A |
|
Net Loss From Continuing Operations |
($85.2 million) |
($191.9 million) |
55.6% |
|
Net Loss Per Share |
($0.89) |
($13.68) |
93.5% |
Data source: Yahoo Finance!
What happened with Juno this quarter?
Juno's raw financial results demonstrate two important truths for the company. First, things are improving -- with some revenue coming in from the company's collaboration with Celgene (CELG +0.00%). Second, there's still a long way to go for Juno to become profitable.
At this stage in its life, though, Juno's clinical and operational developments matter more than financial results. On this front, the company accomplished several things during the fourth quarter of 2015, including:
- Presented promising data at the American Society of Hematology (ASH) meeting in December for JCAR015, a CD19-directed CAR T cell drug currently in phase 2 clinical trials focusing on treatment of relapsed/refractory (r/r) acute lymphoblastic leukemia (ALL).
- Reported data at ASH from the phase 1 trial of JCAR014 targeting treatment of non-Hodgkin lymphoma plus data from JCAR014 in relapsed/refractory chronic lymphocytic leukemia in patients previously treated with Imbruvica.
- Received a thumbs-up from the Food and Drug Administration to begin clinical studies of a combination of JCAR014 and durvalumab, an investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor developed by AstraZeneca's MedImmune group.
What management had to say
Juno's President and CEO, Hans Bishop, focused on the company's accomplishments throughout 2015. He said:
2015 was a year of significant progress for our clinical pipeline with encouraging data from our most advanced pipeline candidates, particularly in B cell malignancies. We are preparing for our first potential launch in r/r adult ALL as early as 2017, which if successful, creates the opportunity to change the current standard of care. We also made significant advances in building our capabilities to support our goal of developing best-in-class CAR and TCR therapies. We look forward to a strong 2016 as we leverage these capabilities, our pipeline, and our people to create value for patients and shareholders.
Looking forward
Running out of cash is a big worry for many development-stage biotechs, but that's not a problem for Juno in the foreseeable future. Thanks mainly to Celgene's purchase of over 9 million shares in the third quarter, Juno had $1.22 billion in cash, cash equivalents, and marketable securities as of the end of 2015.
Expect Juno's cash burn to accelerate, though. In 2015, the company burned through $147.8 million. Juno projects cash burn for 2016 will be between $220 million and $250 million. That range includes an assumption that Celgene exercises its rights to co-develop, co-promote, and share profits in Juno's CD19 pipeline.
Progress from those experimental CD19 drugs will definitely be something for investors to watch. Juno plans to continue enrollment in multiple clinical trials. The phase 2 study of JCAR015 in treating ALL patients is the most important. Juno thinks that it could potentially gain FDA approval based on this study by early 2017. Good news for JCAR015 could definitely help Juno end 2016 much better than it started the year.
