– Nine product candidates in clinical trials
against eight different targets –
– Pivotal trial for JCAR017 in r/r DLBCL
expected to start in 2017 –
– Phase I JCAR017 demonstrates 80% overall
response and 60% complete response in r/r DLBCL –
– Discontinuing development of JCAR015 in
r/r adult ALL to focus on defined cell product in this setting
–
– 2016 year end cash position of $922.3
million –
– 2017 cash burn guidance of $270 million to
$300 million, including $22 million to $27 million in capital
expenditures –
– Conference call today at 5:00 p.m. Eastern
Time –
Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical
company developing innovative cellular immunotherapies for the
treatment of cancer, today reported financial results and business
highlights for the fourth quarter and year ended December 31,
2016.
“2016 was a year of progress and learning for Juno and the
cancer immunotherapy field. We continue to experience encouraging
signs of clinical benefit in our trial addressing NHL, but we also
recognize the unfortunate and unexpected toxicity we saw in our
trial addressing ALL with JCAR015. We have decided not to move
forward with the ROCKET trial or JCAR015 at this time, even though
it generated important learnings for us and the immunotherapy
field. We remain committed to developing better treatments for
patients battling ALL and believe an approach using our defined
cell technology is the best platform to pursue. We intend to begin
a trial with a defined cell product candidate in adult ALL next
year. We look forward to sharing detailed data supporting our
learnings from the ROCKET trial at an upcoming scientific
conference," said Hans Bishop, Juno’s President and Chief Executive
Officer. "Looking forward into 2017, we continue to be optimistic
about the progress we are making with JCAR017 and our pipeline more
broadly. We expect 2017 will be a data-rich year of key insights,
based on up to 20 ongoing trials by year end, and we plan to
present data from these trials as appropriate throughout the
year.”
2016 and Recent Corporate Highlights
Clinical Update:
- CD19 Portfolio – Meaningful
developments with Juno's CD19-directed portfolio across B cell
malignancies including relapsed / refractory (r/r) non-Hodgkin
lymphoma (NHL), r/r chronic lymphocytic leukemia (CLL), and r/r
acute lymphoblastic leukemia (ALL):
- NHL – Investigators presented
interim results at the American Society of Hematology meeting in
December 2016 (ASH 2016) from the Phase I TRANSCEND study in
patients with r/r diffuse large B cell lymphoma (DLBCL), follicular
lymphoma grade 3B, and mantle cell lymphoma (MCL) who were treated
with fludarabine/cyclophosphamide (flu/cy) lymphodepletion and
JCAR017. Topline results as of a data cutoff date of November 23,
2016 included a 12/20 (60%) complete response rate in patients with
r/r DLBCL (N=19) and follicular lymphoma grade 3B (N=1) treated
with a single dose of JCAR017 at dose level 1 (5x107 cells).
No severe cytokine release syndrome (sCRS) was observed; grade 3-4
neurotoxicity was observed in 3/22 (14%) patients, and of those
evaluable for reversibility (N=2), all resolved. In addition, the
side effect profile of JCAR017 plus its cell persistence suggest
the potential for combination therapy. The Phase I TRANSCEND trial
continues, enrolling more patients at dose levels 1 and 2. Juno
intends to initiate a pivotal trial in the U.S. in patients with
r/r DLBCL in 2017.
- The Phase Ib combination trial of
JCAR014 and MedImmune’s investigational programmed death ligand 1
(PD-L1) immune checkpoint inhibitor, durvalumab, in patients with
r/r NHL has begun. The investigational new drug application (IND)
has cleared for, and Juno plans to enroll patients in 2017 in, a
Phase I trial in certain adult B cell malignancies, including r/r
NHL, for a CD19 product candidate that incorporates a fully human
binding domain. Juno also expects to begin a Phase I trial in r/r B
cell malignancies for its CD19/4-1BB ligand armored CAR in
2017.
- CLL – Investigators presented
interim results at ASH 2016 from a Phase I/II study of heavily
pre-treated patients with CLL who failed treatment with ibrutinib,
a standard-of-care treatment for high-risk and elderly individuals
with CLL. Fifteen of 17 (88%) efficacy-evaluable patients who had
bone marrow disease at the start of the trial and treated with
flu/cy at the two lowest doses of JCAR014 had a complete marrow
response by flow cytometry as of the data cutoff date of December
4, 2016. Fourteen of the complete bone marrow response patients had
a response assessment by IgH deep sequencing, a more sensitive
measure than flow cytometry, with 7/14 (50%) having no detectable
disease. As of the data cutoff date, all seven of these patients
were alive and progression free with follow-up ranging from 2 to 24
months. Two of 24 (8%) patients developed grade 3-5 sCRS and 6/24
(25%) patients developed grade 3-5 neurotoxicity. There was
one treatment-related mortality (4%) in the CLL portion of the
trial in a patient who received flu/cy lymphodepletion, with
both grade 5 sCRS and cerebral edema. Plans to study JCAR014 in
combination with ibrutinib in CLL are underway, with a cohort
expected to begin enrollment in early 2017. Juno is planning to
file an IND in 2017 in support of a potential Juno-sponsored Phase
I/II trial with JCAR017 in CLL.
- ALL – Juno experienced a
setback in 2016 to its adult r/r ALL development plans when a
greater than expected incidence of severe neurotoxicity was
observed, along with five deaths from cerebral edema, in patients
treated in the Phase II trial with JCAR015 in adult patients with
r/r ALL, referred to as the ROCKET trial. The Phase II trial was
placed on clinical hold by the FDA briefly in July 2016. In
November 2016, the trial was again placed on hold and has remained
on hold while Juno conducted an investigation into the toxicity.
Through the investigation Juno identified multiple factors that may
have contributed to this increased risk, including patient specific
factors, the conditioning chemotherapy patients received, and
factors related to the product. Although Juno believes there are
protocol modifications and process improvements that could enable
Juno to proceed with JCAR015 in clinical testing in adult r/r ALL,
Juno would first need to establish preliminary safety and dose in a
Phase I trial. As a result of the timing delay that would entail
and Juno’s belief that it has other product candidates in its
pipeline that are likely to provide improved efficacy and
tolerability, Juno, in collaboration with partner Celgene, has made
a strategic decision to cease development of JCAR015 at this time
and to redirect associated resources to the development of a
defined cell product candidate in the adult r/r ALL setting.
- As for pediatric ALL, investigators
presented results at ASH 2016 from the Phase I portion of the Phase
I/II Pediatric Leukemia Adoptive Therapy-02 (PLAT-02) study with
JCAR017 in 43 evaluable children and young adults with r/r
CD19-positive ALL. The presentation updated data previously
presented at ASCO in June 2016: 40/43 (93%) patients
experienced a minimal residual disease (MRD)-negative complete
remission (CR) as measured by flow cytometry as of the data cutoff
date of July 19, 2016. In patients who received preconditioning
with flu/cy lymphodepletion, 14/14 (100%) patients achieved a
MRD-negative CR. The estimated 12-month event-free survival across
all patients in the trial was 50.8% (95%CI 36.9, 69.9) and overall
survival (OS) was 69.5% (95%CI 55.8, 86.5). Grade 3-4 neurotoxicity
and sCRS were each observed in 10/43 (23%) patients.
- Across our CD19 portfolio, the most
common severe treatment-related side effects are sCRS and severe
neurotoxicity, including several cases of fatal cerebral edema.
Other treatment emergent adverse events observed in at least 25% of
patients across our CD19 product candidates include cytopenias,
febrile neutropenia, electrolyte abnormalities, hypotension,
infections, pyrexia, fatigue, and hyperglycemia. All of Juno’s
product candidates are investigational and their safety and
efficacy have not been established.
- Pipeline Portfolio – Juno
continues to conduct clinical trials beyond the CD19 target:
- JCAR018 – This CD22-directed,
fully-human CAR T cell product candidate has the potential to treat
or prevent CD19-negative relapses. Investigators from the National
Cancer Institute (NCI) presented early data from the trial at ASH
2016, with 7/8 (88%) of r/r ALL patients achieving a MRD-negative
CR at dose level 2 (1x106 cells/kg) as measured by flow cytometry,
as of a data cutoff date of October 4, 2016. Three of 7 (43%)
patients who achieved an MRD-negative CR at dose level 2 were in
ongoing remission ranging from 3 to 12 months. This trial continues
to enroll patients. Combining a CD19-directed therapy and a
CD22-directed therapy may increase the selection pressure on the
cancer and significantly reduce the overall risk of relapse,
particularly in patients with ALL. Juno is currently investigating
pre-clinical constructs to better understand the optimal way to
target these two targets in the same product.
- JTCR016 – This WT-1-directed, T
cell receptor (TCR) cell product candidate is currently being
studied in acute myeloid leukemia (AML), refractory mesothelioma,
and non-small cell lung cancer. In the first three solid organ
tumor patients treated as of the data cutoff date of April 1, 2016,
all with mesothelioma, preliminary data presented at the American
Association for Cancer Research Annual Meeting 2016 showed one
patient with an ongoing partial response to the WT-1 TCR and one
with stable disease. The clinical activity appeared to correlate
with the pharmacokinetics of the engineered T cells, as the patient
with the partial response had the best T cell expansion and
persistence. JTCR016 was generally well-tolerated in these three
refractory mesothelioma patients, with no evidence of sCRS or
severe neurotoxicity.
- Announced breakthrough therapy
designation and access to the Priority Medicines (PRIME) scheme for
investigational drug JCAR017. JCAR017 received breakthrough
therapy designation from the FDA for the treatment of patients with
r/r aggressive large B-cell NHL, including DLBCL, not otherwise
specified (de novo or transformed from indolent lymphoma), primary
mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular
lymphoma. In addition, the European Medicines
Agency (EMA) Committee for Medicinal Products for Human
Use (CHMP) and Committee for Advanced Therapies (CAT) have
granted JCAR017 access to the PRIME scheme for r/r DLBCL.
- Began manufacturing multiple product
candidates at the Juno manufacturing plant in Bothell, WA in
2016.
- Juno continues trials for solid
tumor product candidates against five different targets -
JCAR024 (ROR-1-directed CAR T), JCAR020 (MUC-16-directed armored
CAR T engineered to secrete IL-12), JCAR023 (L1-CAM-directed CAR
T), JTCR016 (WT-1- directed TCR) and a Lewis Y-directed CAR.
- Continued collaboration with
Celgene to leverage T cell therapeutic strategies with an
initial focus on CAR T and TCR therapies. In April 2016, Celgene
exercised its option to develop and commercialize CAR product
candidates from Juno’s CD19 program outside of North America and
China. Celgene paid Juno an option exercise fee of $50.0 million
and the companies now generally share worldwide research and
development expenses for CAR product candidates in the CD19
program. Celgene has commercial rights outside of North America and
China and will pay Juno a royalty at a percentage in the mid-teens
on any future net sales in Celgene's territories of CAR therapeutic
products developed through the CD19 program. Juno retains
commercialization rights in North America and China.
In March 2016, Celgene exercised its annual
right to purchase additional shares of the Company’s common stock
to “top-up” its ownership interest in the Company. Celgene
purchased 1,137,593 shares at a price of $41.32 per share, for an
aggregate cash purchase price of $47.0 million.
- Completed two acquisitions,
which substantially increased Juno’s capabilities, including:
- AbVitro, a leading next-generation
single cell sequencing platform company that has augmented Juno's
capabilities to create best-in-class engineered T cells against a
broad array of cancer targets, including significantly improving
the speed of generating TCR binders, while also enabling
comprehensive profiling of functional immune repertoires with
cancer tissues. Juno and Celgene have agreed in principle to enter
an agreement to license Celgene a subset of the acquired technology
and grant Celgene options to certain related potential product
rights emanating from the acquired technology.
- RedoxTherapies, a privately held
company with an exclusive license to vipadenant, a small molecule
adenosine A2a receptor antagonist that has the potential to disrupt
important immunosuppressive pathways in the tumor microenvironment
in certain cancers. Juno intends to explore this molecule in
combination with its engineered T cell platform and may over time
explore it in other areas as well. The upfront consideration for
the RedoxTherapies acquisition was $10.0 million in cash. The
seller is also eligible to receive payments upon the achievement of
clinical, regulatory, and commercial milestones.
- Completed licensing transactions
to expand Juno’s research and development capabilities, including:
- Memorial Sloan Kettering Cancer Center
(MSK) and Eureka Therapeutics, Inc. for innovative, fully-human
binding domains targeting B cell maturation antigen (BCMA), along
with antibodies against two additional undisclosed multiple myeloma
targets to be used for the potential development and
commercialization of CAR T cell therapies for patients with
multiple myeloma. MSK and Eureka Therapeutics received an
undisclosed upfront payment and are eligible to receive additional
payments upon the achievement of undisclosed clinical, regulatory,
and commercial milestones, and royalties on net sales. Juno has
begun a Phase I trial with a BCMA-directed CAR product candidate at
MSK in patients with multiple myeloma.
- Defeated an attempt to invalidate a
patent exclusively licensed by Juno and sued Kite Pharma,
Inc., regarding a CAR T technology that can be used, for
example, for the treatment of B cell malignancies. In August
2015, Kite filed a petition with the U.S. Patent &
Trademark Office (USPTO) for inter partes review in an attempt to
invalidate U.S. Patent No. 7,446,190 by challenging all of its
claims. Following proceedings, the USPTO Patent Trial and Appeal
Board issued a final written decision upholding all the claims of
this patent. Kite is appealing this decision to the U.S. Court of
Appeals for the Federal Circuit. Juno exclusively licenses the ’190
patent, titled “Nucleic Acids Encoding Chimeric T Cell Receptors,”
from Sloan Kettering Institute for Cancer Research, an
affiliate of MSK. The patent covers, among other things, a
construct for a CD19-targeted CAR T cell treatment that employs a
certain CD28 costimulatory domain. In addition, Juno is
suing Kite, seeking a declaratory judgment that Kite’s lead
product candidate, KTE-C19, will infringe the patent when
commercially produced.
- Formed JW Therapeutics (Shanghai)
Co., Ltd., a new company in China along with WuXi AppTec, with
a mission to develop novel cell-based immunotherapies for patients
with hematologic and solid organ cancers in China. The new company
will leverage Juno's world-class CAR and TCR technologies and WuXi
AppTec's research and development and manufacturing platform and
local expertise.
- Announced the opening of a new,
best-in-class clinical trials unit dedicated to
immuno-oncology, in collaboration with the University of
Washington, the Seattle Cancer Care Alliance, and the Fred
Hutchinson Cancer Research Center (FHCRC). The clinical trials unit
has been established to accelerate the clinical care of patients
and the generation of translational medicine insights with
cutting-edge immuno-oncology therapeutic candidates.
- Hired key talent, including the
appointment of Corsee Sanders as Executive Vice President and Head
of Development Operations.
Fourth Quarter and 2016 Financial Results
- Cash Position: Cash, cash
equivalents, and marketable securities as of December 31, 2016
were $922.3 million compared to $1.22 billion as of
December 31, 2015.
- Cash Burn: Cash burn in 2016,
excluding cash inflows and outflows from business development
activities, was $232.2 million, consistent with guidance of $220.0
million to $250.0 million. Included in cash burn in 2016 was $56.2
million for property and equipment, of which $18.2 million was for
the purchase of Juno's manufacturing facility. Excluding cash
inflows and outflows from business development activities, cash
burn in 2015 was $147.8 million including $28.2 million for the
build out of Juno's manufacturing facility and general lab
equipment. The cash burn increase of $84.4 million was primarily
driven by cash outflows in connection with the overall growth of
the business including clinical, manufacturing, and research, costs
to build out Juno's headquarters facility, and purchases of
manufacturing equipment. These increases were offset by $19.4
million received from Celgene for reimbursement of costs incurred
by Juno in connection with the CD19 program.
Cash burn in the fourth quarter of 2016,
excluding cash inflows and outflows from business development
activities, was $106.6 million including $38.4 million for the
purchase of property and equipment, of which $18.2 million was for
the purchase of Juno's manufacturing facility. Cash burn in the
fourth quarter of 2015 was $51.4 million, including $4.8 million
for capital expenditures. The cash burn increase of $55.2 million
was primarily due to cash outflows in connection with the overall
growth of the business, including clinical, manufacturing, and
research costs, the purchase of Juno's manufacturing facility,
build out of its new headquarters facility, and purchase of
manufacturing equipment. These increases were offset by $10.2
million received from Celgene for reimbursement of costs incurred
by Juno in connection with the CD19 program.
- Revenue: Revenue for the three
and twelve months ended December 31, 2016 was $21.2 million and
$79.4 million, respectively, compared to $4.2 million and $18.2
million for the three and twelve months ended December 31, 2015,
respectively. The increases of $17.0 million and $61.2 million in
the three and twelve months ended December 31, 2016, respectively,
were due primarily to revenue recognized in connection with the
Celgene collaboration and CD19 opt-in.
- R&D Expenses: Research and
development expenses for the three and twelve months ended December
31, 2016, inclusive of non-cash expenses and computed in accordance
with GAAP, were $57.4 million and $264.3 million, respectively,
compared to $75.6 million and $205.2 million for the same periods
in 2015. The increase for the twelve months ended December 31, 2016
was primarily due to increased costs to execute Juno’s clinical
development strategy, manufacture its product candidates, expand
its overall research and development capabilities, milestones
achieved in 2016, and an increase in stock-based compensation
expense. These increases were offset by lower costs to acquire
technology and gains recorded in connection with the change in
value of the success payment and contingent consideration
liabilities. The decrease for the three months ended December 31,
2016 was primarily due to gains recorded in connection with the
change in value of the success payment and contingent consideration
liabilities, partially offset by increased costs to execute Juno’s
clinical development strategy, manufacture its product candidates,
expand its overall research and development capabilities, and an
increase in stock-based compensation expense. For the three and
twelve months ended December 31, 2016, Juno recorded gains of $11.7
million and $32.5 million, respectively, related to Juno’s success
payment liability, compared to expenses of $34.3 million and $51.6
million for the three and twelve months ended December 31,
2015.
- Non-GAAP R&D Expenses:
Non-GAAP research and development expenses for the three and twelve
months ended December 31, 2016 were $73.1 million and $287.6
million, respectively, compared to $41.1 million and $116.5 million
for the same periods in 2015. Non-GAAP research and development
expenses for the three and twelve months ended December 31, 2016
include $8.6 million and $34.5 million of stock-based compensation
expense, respectively, compared to $3.6 million and $10.9 million
for the same periods in 2015. Non-GAAP research and development
expenses in 2016 exclude the following:
- A gain of $11.7 million and $32.5
million for the three and twelve months ended December 31, 2016,
respectively, associated with the change in the estimated fair
value and elapsed service period for Juno’s potential success
payment liabilities to FHCRC and MSK.
- Non-cash stock-based compensation
expense of $0.6 million and $3.9 million for the three and twelve
months ended December 31, 2016, respectively, related to a 2013
restricted stock award to a co-founding director that became a
consultant upon his departure from Juno’s board of directors in
2014.
- A gain of $4.5 million and $9.7 million
for the three and twelve months ended December 31, 2016,
respectively, associated with the change in the estimated fair
value of the contingent consideration liabilities recorded in
connection with the Stage and X-Body acquisitions.
- Upfront payments related to technology
licensing and the RedoxTherapies acquisition of $15.0 million for
the twelve months ended December 31, 2016.
- Non-GAAP research and development
expenses in 2015 exclude the following:
- An expense of $34.3 million and $51.6
million for the three and twelve months ended December 31, 2015,
respectively, associated with the change in estimated fair value
and elapsed accrual period for Juno’s potential success payment
liabilities to FHCRC and MSK.
- Non-cash stock-based compensation
expense of $1.4 million and $6.2 million for the three and twelve
months ended December 31, 2015, respectively, related to a 2013
restricted stock award to a co-founding director that became a
consultant upon his departure from Juno’s board of directors in
2014.
- A gain of $1.1 million for the fourth
quarter of 2015 in the estimated fair value of the contingent
consideration recorded in connection with the Stage and X-Body
acquisitions.
- Upfront payments related to license
agreements of $30.8 million for the twelve months ended December
31, 2015 associated with the Editas and Fate Therapeutics
collaborations.
- G&A Expenses: General and
administrative expenses on a GAAP basis for the three and twelve
months ended December 31, 2016 were $19.5 million and $70.7
million, respectively, compared to $16.0 million and $57.2 million
for the same periods in 2015. The increase of $3.5 million in the
fourth quarter of 2016 compared to the same period in 2015 was due
to an increase in consulting costs related to commercial readiness
and legal costs, offset by decreased costs incurred to support
business development activities. The increase of $13.5 million in
2016 compared to 2015 was primarily due to increased personnel
costs, including stock-based compensation, and increased consulting
costs related to commercial readiness, offset by decreased costs
incurred to support business development activities.
General and administrative expenses include
$5.2 million and $21.0 million of non-cash stock-based compensation
expense for the three and twelve months ended December 31, 2016,
respectively, compared to $5.4 million and $14.9 million for the
same periods in 2015.
- GAAP Net Loss: Net loss for the
three and twelve months ended December 31, 2016 was $52.8 million,
or $0.51 per share, and $245.6 million, or $2.42 per share,
respectively, compared to $85.2 million, or $0.89 per share and
$239.4 million, or $2.72 per share for the same periods in
2015.
- Non-GAAP Net Loss: Non-GAAP net
loss, which incorporates the non-GAAP R&D expense, for the
three and twelve months ended December 31, 2016 was $68.5 million,
or $0.65 per share, and $268.9 million, or $2.65 per share,
respectively, compared to $50.7 million, or $0.53 per share, and
$150.7 million, or $1.72 per share, respectively, for the same
periods in 2015.
A reconciliation of GAAP net loss to non-GAAP net loss is
presented below under “Non-GAAP Financial Measures.”
2017 Financial Guidance
Juno expects 2017 cash burn, excluding cash inflows or outflows
from upfront payments related to business development activities,
of between $270 million and $300 million.
- Operating burn estimated to be between
$245 million and $275 million.
- Capital expenditures estimated to be
between $22 million and $27 million, the majority of which are
related to one-time infrastructure build-outs.
Conference Call Information
Juno will host a conference call today to review Juno’s
financial results for the fourth quarter and year ended
December 31, 2016 beginning at 2:00 p.m. Pacific Time
(PT)/5:00 p.m. Eastern Time (ET). Analysts and investors can
participate in the conference call by dialing (855) 780-7198 for
domestic callers and (631) 485-4870 for international callers,
using the conference ID# 60783648.
The webcast can be accessed live on the Investor Relations page
of Juno's website, www.JunoTherapeutics.com, and will be available
for replay for 30 days following the call.
About Juno
Juno Therapeutics is building a fully integrated
biopharmaceutical company focused on developing innovative cellular
immunotherapies for the treatment of cancer. Founded on the vision
that the use of human cells as therapeutic entities will drive one
of the next important phases in medicine, Juno is developing
cell-based cancer immunotherapies based on chimeric antigen
receptor and high-affinity T cell receptor technologies to
genetically engineer T cells to recognize and kill cancer. Juno is
developing multiple cell-based product candidates to treat a
variety of B-cell malignancies as well as solid tumors. Several
product candidates have shown compelling clinical responses in
clinical trials in refractory leukemia and lymphoma conducted to
date. Juno's long-term aim is to leverage its cell-based platform
to develop new product candidates that address a broader range of
cancers and human diseases. Juno brings together innovative
technologies from some of the world's leading research
institutions, including the Fred Hutchinson Cancer Research
Center, Memorial Sloan Kettering Cancer Center, Seattle
Children's Research Institute, the University of California, San
Francisco, and The National Cancer Institute. Juno
Therapeutics has an exclusive license to the St. Jude Children’s
Research Hospital patented technology for CD19-directed product
candidates that use 4-1BB, which was developed by Dario Campana,
Chihaya Imai, and St. Jude Children’s Research Hospital. Juno's
product candidate JCAR017 was developed in collaboration with SCRI
and others.
About the Juno-Celgene Collaboration
Celgene Corporation and Juno Therapeutics formed a collaboration
in June 2015 under which the two companies will leverage T cell
therapeutic strategies to develop treatments for patients with
cancer and autoimmune diseases with an initial focus on chimeric
antigen receptor (CAR) and T cell receptor (TCR) technologies. In
April 2016, Celgene exercised its option to develop and
commercialize the Juno CD19 program outside North America and
China.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, Section 27A of the Securities Act of 1933, and Section 21E of
the Securities Exchange Act of 1934, including statements regarding
Juno’s mission, progress, and business plans; clinical benefits;
clinical trial results and the implications thereof; clinical trial
plans and regulatory approval timelines; timing of future clinical
data; the potential of CD22/CD19 combinations, combinations of CAR
T cells with checkpoint inhibitors, and CAR T constructs with fully
human binding domains; the potential of acquired or licensed
technology and capabilities; the potential of the Celgene
collaboration; the potential of JW Therapeutics (Shanghai) Co.,
Ltd.; the timing or outcome of any dispute resolution proceedings;
and 2017 cash burn forecast. Forward-looking statements are subject
to risks and uncertainties that could cause actual results to
differ materially from such forward-looking statements, and
reported results should not be considered as an indication of
future performance. These risks and uncertainties include, but are
not limited to, risks associated with: the success, cost, and
timing of Juno's product development activities and clinical
trials; Juno's ability to obtain regulatory approval for and to
commercialize its product candidates; Juno's ability to establish a
commercially-viable manufacturing process and manufacturing
infrastructure; regulatory requirements and regulatory
developments; success of Juno's competitors with respect to
competing treatments and technologies; Juno's dependence on
third-party collaborators and other contractors in Juno's research
and development activities, including for the conduct of clinical
trials and the manufacture of Juno's product candidates; Juno's
dependence on Celgene for the development and commercialization
outside of North America and China of Juno’s CD19 product
candidates and any other product candidates for which Celgene
exercises an option; Juno’s dependence on JW Therapeutics
(Shanghai) Co., Ltd, over which Juno does not exercise complete
control, for the development and commercialization of product
candidates in China; Juno's ability to obtain, maintain, or protect
intellectual property rights related to its product candidates;
amongst others. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to Juno's business in general, see Juno's Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
November 9, 2016 and Juno’s other periodic reports filed with the
Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof. Juno disclaims any
obligation to update these forward-looking statements.
Juno Therapeutics, Inc.
Unaudited Consolidated Balance
Sheets
(In thousands)
December 31, 2016 2015
ASSETS Current assets: Cash, cash equivalents, and
short-term marketable securities $ 732,575 $ 943,411 Accounts
receivable 13,286 315 Prepaid expenses and other current assets
26,471 8,113 Total current assets 772,332 951,839
Property and equipment, net 81,734 42,086 Long-term marketable
securities 189,706 272,888 Goodwill 221,306 122,092 Intangible
assets 77,986 50,177 Other assets 6,400 6,046 Total
assets $ 1,349,464 $ 1,445,128
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and
accrued liabilities $ 41,237 $ 37,624 Success payment liabilities
22,786 64,829 Contingent consideration 7,605 1,905 Deferred revenue
43,264 15,370 Total current liabilities 114,892
119,728 Build-to-suit lease obligation, less current portion —
9,294 Contingent consideration, less current portion 13,291 35,361
Deferred revenue, less current portion 120,054 129,831 Deferred tax
liabilities 5,152 8,946 Other long-term liabilities 18,374 435
Stockholders’ equity: Common stock 11 10 Additional paid-in-capital
1,911,769 1,733,263 Accumulated other comprehensive loss (2,842 )
(6,083 ) Accumulated deficit (831,237 ) (585,657 ) Total
stockholders’ equity 1,077,701 1,141,533 Total
liabilities and stockholders’ equity $ 1,349,464 $ 1,445,128
Juno Therapeutics, Inc.
Unaudited Consolidated Statements of
Operations
(In thousands, except per share
amounts)
Three Months Ended December 31, Year Ended
December 31, 2016 2015 2016
2015 Revenue $ 21,153 $ 4,152 $ 79,356 $ 18,215 Operating
expenses: Research and development 57,398 75,623 264,285 205,160
General and administrative 19,465 15,971 70,675
57,155 Total operating expenses 76,863 91,594
334,960 262,315 Loss from operations (55,710 )
(87,442 ) (255,604 ) (244,100 ) Other-than-temporary impairment
loss — — (5,490 ) — Interest income, net 1,547 1,021 5,869 1,730
Other income (expenses), net (141 ) 1 (1,012 ) 234
Loss before income taxes (54,304 ) (86,420 ) (256,237 ) (242,136 )
Benefit for income taxes 1,526 1,207 10,657
2,760 Net loss $ (52,778 ) $ (85,213 ) $ (245,580 ) $
(239,376 ) Net loss per share, basic and diluted $ (0.51 ) $ (0.89
) $ (2.42 ) $ (2.72 ) Weighted average common shares outstanding,
basic and diluted 103,008 95,374 101,476
88,145
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with
generally accepted accounting principles in the United States
(GAAP), Juno uses certain non-GAAP financial measures to evaluate
its business. Juno’s management believes that these non-GAAP
financial measures are helpful in understanding Juno’s financial
performance and potential future results. These are not meant to be
considered in isolation or as a substitute for comparable GAAP
measures and should be read in conjunction with Juno’s financial
statements prepared in accordance with GAAP. These non-GAAP
measures differ from GAAP measures with the same captions, may be
different from non-GAAP financial measures with the same or similar
captions that are used by other companies, and do not reflect a
comprehensive system of accounting. Juno’s management uses these
supplemental non-GAAP financial measures internally to understand,
manage, and evaluate Juno’s business and make operating decisions.
In addition, Juno’s management believes that the presentation of
these non-GAAP financial measures is useful to investors because
they enhance the ability of investors to compare Juno’s results
from period to period and allows for greater transparency with
respect to key financial metrics Juno uses in making operating
decisions. Juno endeavors to compensate for the limitation of the
non-GAAP measures presented by also providing the most directly
comparable GAAP measures and descriptions of the reconciling items
and adjustments to derive the non-GAAP measures. The following is a
reconciliation of GAAP to non-GAAP financial measures:
Juno Therapeutics, Inc.
Unaudited Reconciliation of GAAP to
Non-GAAP Net Loss
(In thousands, except per share
amounts)
Three Months Ended December 31, Year Ended
December 31, 2016 2015 2016
2015 Net loss - GAAP $ (52,778 ) $ (85,213 ) $ (245,580 ) $
(239,376 ) Adjustments: Success payment (gain) expense (1) (11,716
) 34,272 (32,474 ) 51,558 Non-cash stock-based compensation expense
(2) 589 1,374 3,918 6,208 Change in fair value of contingent
consideration (3) (4,549 ) (1,125 ) (9,724 ) 78 Upfront payments
related to the acquisition of technology (4) — —
15,000 30,810 Net loss - Non-GAAP $ (68,454 ) $
(50,692 ) $ (268,860 ) $ (150,722 ) Net loss per share - GAAP $
(0.51 ) $ (0.89 ) $ (2.42 ) $ (2.72 ) Adjustments: Success payment
(gain) expense (1) (0.11 ) 0.36 (0.32 ) 0.58 Non-cash stock-based
compensation expense (2) 0.01 0.01 0.04 0.07 Change in fair value
of contingent consideration (3) (0.04 ) (0.01 ) (0.10 ) — Upfront
payments related to the acquisition of technology (4) — —
0.15 0.35 Net loss per share, basic and
diluted - Non-GAAP $ (0.65 ) $ (0.53 ) $ (2.65 ) $ (1.72 ) Weighted
average common shares outstanding, basic and diluted 103,008
95,374 101,476 88,145
Juno Therapeutics, Inc. Unaudited Reconciliation of GAAP
to Non-GAAP Research and Development Expense
(In thousands)
Three Months Ended December 31, Year Ended
December 31, 2016 2015 2016
2015 Research and development expense - GAAP $ (57,398 ) $
(75,623 ) $ (264,285 ) $ (205,160 ) Adjustments: Success payment
(gain) expense (1) (11,716 ) 34,272 (32,474 ) 51,558 Non-cash
stock-based compensation expense (2) 589 1,374 3,918 6,208 Change
in fair value of contingent consideration (3) (4,549 ) (1,125 )
(9,724 ) 78 Upfront payments related to the acquisition of
technology (4) — — 15,000 30,810
Research and development expense - Non-GAAP $ (73,074 ) $ (41,102 )
$ (287,565 ) $ (116,506 )
(1) The success payment expense (gain) represents the change in
the estimated fair value of the success payment obligations and the
associated elapsed service period. As of December 31, 2016,
the estimated fair values of the success payment liabilities to
FHCRC and MSK on the consolidated balance sheets, after giving
effect to the success payments achieved in December 2015, were
approximately $13.3 million and $9.5 million, respectively. In
December 2015, success payments of $75.0 million, less indirect
costs of $3.3 million, and $10.0 million, less indirect costs of
$1.0 million, were triggered to FHCRC and MSK, respectively. Juno
elected to make the payments in shares of its common stock and
thereby issued 1,601,085 shares to FHCRC in December 2015 and
240,381 shares to MSK in March 2016. In April 2016, Juno
repurchased from MSK the 240,381 shares of common stock that had
been issued to MSK. If success payment thresholds are met in the
future, Juno may pay FHCRC and MSK the applicable success payment
in cash or publicly-traded equity at Juno’s election. The success
payment liabilities are subject to re-measurement each reporting
period and may fluctuate from quarter-to-quarter and year-to-year,
sometimes significantly, resulting in either an expense or a gain
depending on the trading price of Juno common stock, estimated
term, expected volatility, risk-free interest rate, estimated
number and timing of valuation measurement dates, and estimated
indirect costs that are creditable against the success payments to
FHCRC and MSK.
(2) This relates to a restricted stock grant in 2013 to a former
co-founding director who became a consultant upon his departure
from Juno’s board of directors in 2014. Unlike other outstanding
awards to Juno’s employees, scientific founders, and continuing
directors, the value of this restricted stock award is subject to
re-measurement each reporting period as the award vests and may
result in the associated expense fluctuating from
quarter-to-quarter and year-to-year, sometimes significantly, based
on changes in the trading price of Juno common stock through the
end of the vesting period.
(3) This is the change in the estimated fair value of the
contingent consideration liabilities recorded in connection with
the Stage and X-Body acquisitions after giving effect to a
contingent consideration milestone of €6.0 million paid to the
former shareholders of Stage in the fourth quarter of 2016.
(4) The upfront payments related to the acquisition of
technology in 2016 include payments made in connection with
technology licensing and the acquisition of RedoxTherapies. The
upfront payments related to the acquisition of technology in 2015
include payments in connection with the Editas and Fate
Therapeutics collaborations.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170301006434/en/
Juno Therapeutics, Inc.Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher
Williams, 206-566-5660chris.williams@junotherapeutics.com
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