Receptos Reports Fourth Quarter and Year End 2013 Operational and Financial Results
06 March 2014 - 8:05AM
- Favorable interim results from Phase 2
trial of RPC1063 in relapsing multiple sclerosis consistent with
differentiated profile; top-line data expected mid-2014 -
- Phase 3 trial of RPC1063 in relapsing multiple sclerosis
has begun enrolling patients - - Top-line data
from Phase 2 trial of RPC1063 in ulcerative colitis expected in
mid-2014 - - Conference Call Today at 5
p.m. Eastern Time -
Receptos, Inc. (Nasdaq:RCPT) today provided development program
updates and announced financial results for the fourth quarter and
year ended December 31, 2013.
"The data from the interim analysis of the Phase 2 portion of
our RADIANCE trial was consistent with our differentiation thesis,
and provided support to continue to advance the program,"
said Faheem Hasnain, President and Chief Executive Officer
of Receptos. "Our initiation of the Phase 3 portion of our
RADIANCE trial positions RPC1063 as the potential next-to-market
oral agent for the treatment of relapsing multiple sclerosis. We
look forward to mid-2014 for the top-line results of the Phase 2
portion of RADIANCE, as well as top-line results of TOUCHSTONE, our
Phase 2 study of RPC1063 in ulcerative colitis, and continued
progress with our pipeline programs."
Receptos is developing RPC1063, a small molecule sphingosine
1-phosphate 1 (S1P1) receptor modulator administered orally for
immunology indications. The Company has initiated a Phase 3
trial of RPC1063 in relapsing multiple sclerosis (RMS) and is
currently conducting separate Phase 2 trials in RMS and ulcerative
colitis (UC), with top-line data expected for both trials in
mid-2014. The Company is also developing RPC4046, an
anti-interleukin-13 (IL-13) antibody for an immune-mediated orphan
disease, eosiniphilic esophagitis (EoE), and is in preclinical
development of oral, small molecule, positive allosteric modulators
of the GLP‑1 receptor for the treatment of Type 2
diabetes.
Development Program Updates
RPC1063 in Relapsing Multiple Sclerosis
- In Q4 2013, Receptos completed enrollment in the Phase 2
portion of RADIANCE, its Phase 2/3 trial of RPC1063 in RMS. The
primary objective of the Phase 2 portion of the study is to
demonstrate the superior clinical efficacy of RPC1063 compared to
placebo as measured by a reduction in the cumulative number of
total gadolinium-enhancing lesions determined by MRI from
week 12 to week 24 of study treatment. Top-line data for this
trial is expected in mid-2014.
- In Q4 2013, Receptos completed a pre-planned interim analysis
of the Phase 2 portion of RADIANCE. The interim analysis
focused on several potential product attributes that may be
important for differentiation from other S1P receptor modulators on
the market or in development. These included the overall
adverse event profile; cardiovascular profile; liver enzyme
effects; and preliminary clinical activity and reduction in
lymphocyte count.
- In December 2013, based on these interim results and with the
recommendation of the study's Data Monitoring Committee, the
Company initiated enrollment of the Phase 3 portion of RADIANCE.
This is a randomized, double-blind, double-dummy study designed to
compare 0.5 mg and 1.0 mg of orally administered RPC1063 against
injected interferon beta-1a (Avonex®) in 1,200 patients with
RMS. It is being conducted under a Special Protocol Assessment
(SPA) with the FDA.
RPC1063 in Ulcerative Colitis
- Receptos continues to enroll a randomized Phase 2 study
(TOUCHSTONE) for the treatment of UC, a serious
gastrointestinal disease. The primary objective of TOUCHSTONE is to
demonstrate superior clinical efficacy of RPC1063 compared to
placebo for the induction of clinical remission in patients with
moderately to severely active UC after eight weeks of
treatment. Top‑line results for this Phase 2 study
continue to be anticipated in mid-2014.
RPC4046 in Eosiniphilic Esophagitis
- Receptos is planning a Phase 2 proof‑of‑concept study in
patients with active eosiniphilic esophagitis (EoE), a GI-related
immunological indication that has a prevalence of under 200,000
patients in the U.S. and could qualify for orphan
designation. The Company completed a pre-IND meeting with the
FDA in Q4 2013 intends to file an IND with the Division of
Gastroenterology of the FDA. Submission of an IND in the first
half of 2014 would facilitate the initiation of a Phase 2
trial; a Phase 1 study has previously been completed.
Oral GLP-1 Receptor Positive Allosteric Modulator Program
- Receptos is pursuing a research program for glucagon-like
peptide-1 receptor (GLP-1R) small molecule, positive allosteric
modulators (PAMs) for the treatment of Type 2 diabetes.
Internally developed, orally administered lead compounds have
shown single agent efficacy in a diabetic disease model as well as
activity that is synergistic with metformin in combination
studies.
Key upcoming milestones
- Mid 2014: Top-line results of Phase 2 portion of RPC1063
(RADIANCE) in RMS patients
- Mid 2014 (subsequent to RADIANCE results): Top-line
results of Phase 2 trial of RPC1063 (TOUCHSTONE) in UC
patients
- 1H 2014: Filing of IND with GI division of FDA for RPC4046 in
Eosiniphilic Esophagitis
Financial highlights for the three months and year
ended December 31, 2013
Fourth quarter 2013 financial results (three months ended
December 31, 2013)
- Net loss for the fourth quarter of 2013 was $15.2 million, or
$0.86 per common share, compared to a net loss of $4.5 million, or
$3.08 per common share, for the fourth quarter of 2012.
- Total revenues for the fourth quarter of 2013 were $773,000,
compared to $3.8 million for the fourth quarter of
2012. Revenue during these periods consisted primarily of
amortization of up-front fees and milestone payments, which are
being recognized over the estimated period of performance, and
research and development funding received from our collaborative
arrangements.
- Total operating expenses for the fourth quarter of 2013
were $15.9 million, compared to $8.3
million for the fourth quarter of 2012. Operating expenses for
the fourth quarter of 2013 include $1.3 million of stock
compensation expense, compared to $74,000 of stock compensation
expense for the fourth quarter of 2012.
- Research and development (R&D) expenses were $12.6 million
for the fourth quarter of 2013 compared to $7.5 million for the
fourth quarter of 2012. R&D expenses consist primarily of
costs associated with the preclinical and clinical development of
our product candidates. The increase in R&D costs is primarily
related to increased Phase 2 trial activity and Phase 3 start-up
costs for our Phase 2/3 trial of RPC1063 in RMS, and commencement
of the Phase 2 trial of RPC1063 in UC.
- General and administrative (G&A) expenses were $3.2 million
for the fourth quarter of 2013 compared to $803,000 for the fourth
quarter of 2012. The increase in G&A costs is primarily related
to increased personnel costs, additional stock compensation expense
and additional expenditures on outside services, including
consulting costs, legal and accounting fees, market research and
insurance.
Fiscal year ended December 31, 2013 financial results
- Net loss for 2013 was $50.4 million, or $4.23 per common share,
compared to a net loss of $17.7 million, or $13.73 per common
share, for 2012.
- Total revenues for 2013 were $4.6 million compared to $8.6
million for 2012. Revenue during these periods consisted
primarily of amortization of up-front fees and milestone payments,
which are being recognized over the estimated period of
performance, and research and development funding received from our
collaborative arrangements.
- Total operating expenses for 2013 were $52.5
million compared to $26.4 million for 2012.
Operating expenses for 2013 include $3.0 million of stock
compensation expense, compared to $0.2 million of stock
compensation expense for 2012.
- R&D expenses were $43.6 million for 2013 compared to $22.9
million for 2012. The increase in R&D costs is primarily
related to increased Phase 2 trial activity and Phase 3 start up
costs for our Phase 2/3 trial of RPC1063 in RMS, and commencement
of the Phase 2 trial of RPC1063 in UC.
- G&A expenses were $8.9 million for 2013 compared to $3.4
million for 2012. The increase in G&A costs is primarily
related to increased personnel costs, additional stock compensation
expense and additional expenditures on outside services, including
consulting costs, legal and accounting fees, market research and
insurance.
Other financial highlights
- Receptos had $69.5 million in cash, cash equivalents
and short-term investments as of December 31, 2013. In January
2014, the Company completed an underwritten public offering of
common stock which provided additional net proceeds of
approximately $109.9 million.
- As of December 31, 2013, the Company had term debt of $4.9
million and approximately 18.3 million shares of common stock
outstanding. Upon the closing of the January 2014 offering,
the Company had approximately 22.2 million shares of common stock
outstanding.
Conference Call Today at 5 p.m. Eastern
Time (2:00 p.m. Pacific Time) The Receptos
management team will host a teleconference and webcast to discuss
the fourth quarter and year end 2013 financial results and recent
business highlights. The live call may be accessed by phone by
calling (866) 757-6808 (domestic) or (760) 536-5211
(international), conference ID 33449299. The webcast can be
accessed live on the Investor Relations section of the Receptos
website at www.receptos.com and will be archived for 14 days
following the call. A replay of the call will be available by phone
by calling (855) 859-2056 or (404) 537-3406, conference ID
33449299.
Forward-Looking Statements
Statements contained in this release, other than statements of
historical fact, constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
The words "expects," "believes," "anticipates," "may,"
"intends," "plans," "potential" and similar expressions are
intended to identify forward-looking statements. Investors
are cautioned that these forward-looking statements do not
constitute guarantees of future performance. Forward-looking
statements include, without limitation, statements regarding the
sufficiency of the Company's capital position over future periods,
the ability of the Company to undertake certain development
activities (such as clinical trial enrollment and the conduct of
clinical trials) and to accomplish certain development goals (such
as the availability of clinical trial results), and the safety,
efficacy, projected development timeline and therapeutic and
commercial potential for RPC1063, RPC 4046 and the GLP-1 positive
allosteric modulator program. Such forward-looking statements
are subject to a number of risks and uncertainties that could cause
actual results to differ materially from those anticipated.
These forward-looking statements are based upon the Company's
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of various risks and
uncertainties, which include without limitation risks associated
with the process of discovering, developing and commercializing
drug candidates that are safe and effective for use as human
therapeutics. These and other risks regarding the Company's
financial position and research and development programs are
described in detail in the Company's SEC filings, including the
Company's Quarterly Reports on Form 10-Q and the Registration
Statement on Form S-1 which was declared effective on
January 8, 2014. All forward-looking statements contained
in this release speak only as of the date on which they were first
made by the Company, and the Company undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after such date.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic
candidates for the treatment of immune and metabolic diseases. The
Company's lead program, RPC1063, a small molecule sphingosine
1-phosphate 1 (S1P1) receptor modulator administered orally for
immunology indications, including relapsing multiple sclerosis
(RMS) and inflammatory bowel disease (IBD), which includes
ulcerative colitis (UC). The Company is also developing RPC4046, an
anti-interleukin-13 (IL-13) antibody for an
allergic/immune-mediated orphan disease, eosiniphilic esophagitis
(EoE). Receptos has established expertise in high resolution
protein crystal structure determination, biology and drug discovery
for G-protein-coupled receptors (GPCRs).
|
|
RECEPTOS,
INC. |
CONSOLIDATED FINANCIAL
RESULTS |
(In thousands, except per share
amounts) |
|
|
|
|
Three months
ended December 31, |
Year ended
December 31, |
|
2013 |
2012 |
2013 |
2012 |
|
|
|
|
|
Collaborative
revenue |
$773 |
$3,838 |
$4,641 |
$8,647 |
Operating expenses: |
|
|
|
|
Research and development |
12,624 |
7,493 |
43,585 |
22,927 |
General and administrative |
3,248 |
803 |
8,949 |
3,430 |
|
|
|
|
|
Total operating expenses |
15,872 |
8,296 |
52,534 |
26,357 |
|
|
|
|
|
Loss from
operations |
(15,099) |
(4,458) |
(47,893) |
(17,710) |
Other income (expense) |
(145) |
2 |
(427) |
-- |
|
|
|
|
|
Net loss |
(15,244) |
(4,456) |
(48,320) |
(17,710) |
Preferred stock deemed dividend |
-- |
-- |
(2,056) |
-- |
|
|
|
|
|
Net loss attributable to common
stockholders |
($15,244) |
($4,456) |
($50,376) |
($17,710) |
|
|
|
|
|
Net loss per common share, basic and
diluted |
($0.86) |
($3.08) |
($4.23) |
($13.73) |
|
|
|
|
|
Shares used to compute net loss per common
share, basic and diluted |
17,806 |
1,448 |
11,916 |
1,289 |
|
|
|
|
|
Note - The calculation of net
loss per common share for the three and twelve months ended
December 31, 2012 excludes the impact of the conversion of all of
the Company's outstanding Series A and B convertible preferred
stock into 9,644,000 shares of common stock in connection with our
initial public offering in May 2013. |
|
|
|
|
|
|
RECEPTOS, INC. |
|
|
CONSOLIDATED BALANCE SHEET
DATA |
|
|
(IN THOUSANDS) |
|
|
|
As of December
31, |
|
2013 |
2012 |
|
|
|
Cash, cash equivalents and short-term
investments |
$69,490 |
$5,427 |
Working capital (deficit) |
54,263 |
(6) |
Total assets |
71,228 |
6,903 |
Term debt |
4,915 |
-- |
Total liabilities |
20,433 |
7,070 |
Common stock and additional paid-in
capital |
146,698 |
7,606 |
Total stockholders' equity (deficit) |
50,795 |
(39,983) |
CONTACT: Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
mrice@lifesciadvisors.com
RECEPTOS, INC. (NASDAQ:RCPT)
Historical Stock Chart
From Aug 2024 to Sep 2024
RECEPTOS, INC. (NASDAQ:RCPT)
Historical Stock Chart
From Sep 2023 to Sep 2024