NeoStem, Inc. Announces 2014 Year-End Financial Results and Provides Corporate Update
March 02 2015 - 4:01PM
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a
biopharmaceutical company developing novel, cell-based personalized
medicine therapies, announced today 2014 year end results and
provided an update on its business.
"We are pleased with our company's achievements in 2014 and look
forward to reporting on our progress advancing the programs in our
diversified and balanced pipeline," said Dr. David J. Mazzo, Chief
Executive Officer of NeoStem. "Our near-term focus will be the
initiation of and continued enrollment in our Phase 3 Intus Study
for stage III recurrent and stage IV metastatic melanoma patients.
This is a program supported by Special Protocol Assessment as well
as Fast Track and Orphan Designations. We expect the first patient
randomization for the study in the second quarter of 2015. We also
are planning the release of one-year data from the PreSERVE Phase 2
trial for acute myocardial infarction on March 15, 2015 at the
Annual Scientific Sessions of the American College of Cardiology.
We expect that these results will further corroborate the results
observed at 6 months of a clinically meaningful effect of our NBS10
candidate."
Business Highlights
Over the past year, NeoStem significantly advanced its
leadership in the cell therapy industry, with highlights
including:
- The acquisition of California Stem Cell, Inc., (CSC) and
execution of the steps necessary to initiate a pivotal Phase 3
trial for its most advanced product candidate, NBS20 (USAN generic
name of eltrapuldencel-T, an autologous melanoma-initiating cell
immune-based therapy intended to eliminate the tumor cells capable
of causing disease recurrence) in recurrent stage III and stage IV
metastatic melanoma patients;
- Announcement of clinically meaningful six-month primary
analysis results from the Company's Phase 2 PreSERVE study for
patients with left ventricular dysfunction post-ST elevation
myocardial infarction (STEMI);
- Announcement of Phase 1 results for a T regulatory cell
immunotherapy for type 1 diabetes, which included preliminary data
indicating safety and tolerability in adult patients, complementing
recently published 12-month data indicating feasibility and
potential efficacy in children with type 1 diabetes;
- Strengthening of executive management with appointments of
David J. Mazzo, PhD as Chief Executive Officer and Robert S. Vaters
as President and Chief Financial Officer;
- Announcement of agreement with Invetech Pty Ltd. to develop a
closed-processing system for cell therapy manufacturing, to provide
a flexible small-scale process suitable for GMP manufacturing of
autologous and other patient-specific products where small-scale is
full scale, while also supporting efficient development of
processes at lower cost prior to transitioning to scaled
volumes.
2014 Year-End Financial Highlights
Total revenue for the year was $17.9 million compared to $14.7
million in 2013, an increase of 22%. Clinical Services,
representing process development and clinical manufacturing
services provided at PCT (NeoStem's wholly-owned subsidiary, a
contract development and manufacturing organization) to its various
clients, were approximately $10.4 million for 2014 compared to $9.1
million for 2013, representing an increase of approximately $1.3
million or 14%.
Research and development expenses were approximately $29.2
million for 2014 compared to $16.9 million for 2013. The increase
was primarily comprised of investment in the Company's (i) targeted
cancer immunotherapy program, including the initiation of the Intus
Phase 3 clinical trial for the Company's lead cancer immunotherapy
product candidate NBS20, (ii) ischemic repair program, including
expenses associated with the PreSERVE AMI Phase 2 clinical trial
for the Company's product candidate NBS10, and (iii) immune
modulation program, primarily due to the Company's efforts to
develop Tregs.
Selling, general and administrative expenses were approximately
$30.8 million for 2014 compared to $21.6 million for 2013. The
increase was related to increased corporate development activities,
expenses associated with the additional California Stem Cell (CSC)
operating activities since its acquisition in May 2014, and
increased corporate infrastructure needed to support the Company's
expanded clinical activities. In addition, the increase was related
to higher equity-based compensation paid in exchange for services
and, in particular, equity awards issued as a bonus for the
successful completion of the CSC acquisition.
Net loss for 2014 was $55.5 million compared with a $39.5
million loss for 2013. Net loss for 2014 excluding non-cash charges
was $45.2 million, compared with $28.7 million for 2013 (see below
for reconciliation).
At December 31, 2014 NeoStem's cash, cash equivalents and
marketable securities totaled $26.3 million.
2015 Outlook
In 2015, NeoStem's management expects significant additional
achievements. The Company's milestones and goals for the year
include:
Therapeutic Pipeline
- Randomization of the first patient for the Intus Phase 3 trial
for NBS20 in the second quarter of 2015;
- Release of one-year data from PreSERVE AMI Phase 2 trial for
NBS10 on March 15, 2015 at the Annual Scientific Sessions of the
American College of Cardiology;
- Finalization of decision on next development steps for NBS10
based on PreSERVE primary analysis results in the second half of
2015;
- Initiation of a Phase 2 study for which NeoStem has received
FDA agreement on the protocol to evaluate in adolescents the
use of NBS03D, a Treg-based therapeutic being developed to treat
type 1 diabetes, in late 2015 or 2016 depending on resource
availability;
- Further exploration of means by which the Company can take
advantage of new regulations in Japan that permit conditional
approval for regenerative medicine products that show sufficient
safety evidence and signals of efficacy.
Commercial Operations
- Continued growth of the Company's client services
business;
- Advancement of initiatives to lower costs and improve
efficiency of manufacturing in anticipation of production for
NeoStem's own products and those of its clients.
Use of Non-GAAP Financial Measures
The Company uses Net Loss Excluding Non-Cash Charges as a
non-GAAP financial measure in evaluating its performance. This
measure represents net loss, less equity-based compensation,
depreciation and amortization, and other non-cash adjustments
included in net loss. The Company believes that providing this
measure to investors provides important supplemental information of
its performance and permits investors and management to evaluate
the core operating performance and cash utilization of the Company
by excluding the use of these non-cash adjustments. Additionally,
the Company believes this information is frequently used by
securities analysts, investors and other interested parties in the
evaluation of performance. Management uses, and believes that
investors benefit from, this non-GAAP financial measure in
assessing the Company's operating results, as well as in planning,
forecasting and analyzing future periods.
Net Loss Excluding Non-Cash Charges has limitations as an
analytical tool, and investors should not consider this measure in
isolation, or as a substitute for analysis of the Company's results
as reported under generally accepted accounting principles in the
United States ("U.S. GAAP"). For example, this measure does not
reflect the Company's cash expenditures, future requirements for
capital expenditures, contractual commitments or cash requirements
for working capital needs. Although depreciation and amortization
are non-cash charges, the assets being depreciated or amortized
often will have to be replaced in the future, and Net Loss
Excluding Non-Cash Charges does not reflect any cash requirements
for such replacements. Given these limitations, the Company relies
primarily on its U.S. GAAP results and uses the Net Loss Excluding
Non-Cash Charges measure only as a supplemental measure of its
financial performance and cash utilization.
GAAP to Non-GAAP Reconciliation
|
|
|
Net Loss Excluding Non-Cash Charges
Reconciliation (unaudited) |
|
|
(in millions) |
For the twelve months ended December 31,
2014 |
For the twelve months ended December 31,
2013 |
Net loss |
$(55.5) |
$(39.5) |
Equity-based compensation |
11.2 |
6.8 |
Depreciation and amortization |
2.2 |
1.6 |
Changes in fair value of derivative
liability |
(0.0) |
(0.1) |
Changes in acquisition-related contingent
consideration |
(3.1) |
1.9 |
Bad debt recovery |
(0.0) |
(0.2) |
Deferred income taxes |
(0.1) |
0.8 |
Accretion on marketable securities |
0.1 |
0.0 |
Net Loss Excluding Non-Cash Charges |
$(45.2) |
$(28.7) |
|
|
|
About NeoStem, Inc.
NeoStem is a biopharmaceutical company pursuing the preservation
and enhancement of human health globally through the development of
novel cell based personalized medicine therapeutics that prevent,
treat or cure disease by repairing and replacing damaged or aged
tissue, cells and organs and restoring their normal function. The
combination of a rich therapeutics pipeline and externally
recognized in-house manufacturing expertise has created an
organization with unique capabilities for cost effective and
accelerated product development. www.neostem.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements reflect management's current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. Forward-looking statements include
statements herein with respect to the successful execution of the
Company's business strategy, the Company's ability to develop and
grow its business, the successful development of cellular therapies
with respect to the Company's research and development and clinical
evaluation efforts in connection with the Company's Targeted
Immunotherapy Program, Ischemic Repair Program, Immune Modulation
Program and other cell therapies, the future of the regenerative
medicine industry and the role of stem cells and cellular therapy
in that industry, and the performance and planned expansion of the
Company's contract development and manufacturing business as well
as its efforts to expand its capabilities into the cell therapy
tools market. The Company's actual results could differ materially
from those anticipated in these forward-looking statements as a
result of various factors. Factors that could cause future results
to materially differ from the recent results or those projected in
forward-looking statements include the "Risk Factors" described in
the Company's Annual Report on Form 10-K filed with the Securities
and Exchange Commission ("SEC") on March 2, 2015 and in the
Company's other periodic filings with the SEC. The Company's
further development is highly dependent on future medical and
research developments and market acceptance, which is outside of
its control.
CONTACT: NeoStem, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@neostem.com
NeoStem, Inc. (NASDAQ:NBS)
Historical Stock Chart
From Jun 2024 to Jul 2024
NeoStem, Inc. (NASDAQ:NBS)
Historical Stock Chart
From Jul 2023 to Jul 2024