UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange act of 1934
Date of report (date of earliest event reported): May 5, 2015
RECEPTOS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware |
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001-35900 |
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26-4190792 |
(State or other jurisdiction of
incorporation or organization) |
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(Commission
File Number |
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(I.R.S. Employer
Identification No.) |
3033 Science Park Road, Suite 300
San Diego, California 92121
(858) 652-5700
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. |
Results of Operations and Financial Condition. |
On May 5, 2015, Receptos, Inc.
issued a press release announcing its results of operations for the quarter ended March 31, 2015. The full text of such press release is furnished as Exhibit 99.1 to this report.
In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall
not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Receptos, Inc. on May 5, 2015. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Date: May 5, 2015 |
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RECEPTOS, INC. |
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By: |
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/s/ Christian Waage |
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Christian Waage |
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Senior Vice President & General Counsel |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Receptos, Inc. on May 5, 2015. |
Exhibit 99.1
Receptos Provides Business Update and Reports First Quarter 2015 Financial Results
- Positive Phase 2 induction and maintenance results for TOUCHSTONE trial of ozanimod (formerly
RPC1063) in Ulcerative Colitis (UC) support broad development program in UC, Crohns Disease -
- Ongoing clinical trials enrolling on schedule -
- Well capitalized, with over $640 million in cash and investments as of March 31, 2015 -
- Conference Call Today at 5:00 p.m. Eastern Time -
San Diego, CA, May 5, 2015 Receptos, Inc. (Nasdaq: RCPT), a biopharmaceutical company developing therapeutic candidates for the
treatment of immune and metabolic diseases, today provided development program updates and reviewed financial results for the first quarter ended March 31, 2015.
With the recently announced positive maintenance results of the TOUCHSTONE Phase 2 trial of ozanimod, we are moving forward expeditiously with a full
Phase 3 program in ulcerative colitis as well as a Phase 2 trial in Crohns disease, said Faheem Hasnain, Chief Executive Officer of Receptos. We have a strong balance sheet and full ownership of the program, and have confidence in
our ability to execute on the development plan for ozanimod in relapsing multiple sclerosis and inflammatory bowel disease. We are also excited about the progress we are making with RPC4046 in eosinophilic esophagitis and our pre-clinical oral GLP-1
program.
Development Program Updates
Ozanimod
(formerly RPC1063) in Relapsing Multiple Sclerosis (RMS)
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In the first quarter of 2015, Receptos reported that it has completed enrollment in the RADIANCE Phase 3 trial of ozanimod in RMS. Receptos is also conducting the SUNBEAM Phase 3 trial of ozanimod in RMS. Each trials is
a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of ozanimod against Avonex® (interferon beta-1a) in approximately 1,200 patients with RMS. The primary objectives of the
RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex® in reducing the annualized relapse rate in patients after two years of therapy and one year of
therapy, respectively. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. |
Ozanimod in
Ulcerative Colitis (UC)
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Receptos reported positive results for the induction and maintenance periods of the TOUCHSTONE Phase 2 trial of ozanimod in patients with moderately-to-severely active UC. The study met all efficacy endpoints with
statistical significance for patients on the 1.0 mg dose after 8 weeks of treatment (induction) and 32 weeks of treatment (maintenance). Safety data were consistent with the favorable profile observed in the Phase 2 trial in RMS. Detailed induction
data were reviewed at an oral podium presentation at the annual meeting of ECCO, the European Crohns and Colitis Organization, and detailed maintenance data are expected to be reviewed at a major medical meeting in the coming months. Receptos
has also been notified that it has been granted an oral presentation during the plenary session at the Digestive Disease Week meeting in May 2015. |
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Based on the positive results from the TOUCHSTONE trial, the Company plans to initiate a Phase 3 program in UC and Phase 2 program in Crohns disease (CD) in 2015. |
RPC4046 in Eosinophilic Esophagitis (EoE)
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Receptos is enrolling patients into the Phase 2 HEROES trial of RPC4046, Receptos development candidate for the treatment of EoE. RPC4046 has been granted Orphan Drug Designation for the treatment of EoE, a
GI-related immunological indication with high unmet need. RPC4046 is a humanized monoclonal antibody directed against interleukin-13 (IL-13), a target which has been validated in other related allergic indications. The trial is expected to be
completed in 1H 2016. |
Oral GLP-1 Receptor Positive Allosteric Modulator Program
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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 glucose lowering and weight loss effects in a diabetic disease model, as well as activity that is synergistic with metformin in combination studies. Receptos expects to identify a lead candidate in
2015 and to subsequently initiate IND-enabling studies. |
Upcoming milestones
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Q2 2015: Presentation at Digestive Disease Week (DDW) meeting for TOUCHSTONE Phase 2 trial of ozanimod in patients with moderately-to-severely active UC |
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2H 2015: Detailed results of maintenance portion of TOUCHSTONE Phase 2 trial of ozanimod in patients with moderately-to-severely active UC |
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1H 2016: Top-line results of Phase 2 HEROES trial of RPC4046, Receptos development candidate for EoE |
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2H 2016: Top-line results of Phase 2 trial of ozanimod in patients with CD |
Financial highlights for the
three months ended March 31, 2015
First quarter 2015 financial results
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Total revenues for the first quarter of 2015 were $0, compared to $1.4 million for the first quarter of 2014. Revenue during the first quarter of 2014 consisted primarily of amortization of upfront fees and milestone
payments and R&D funding received from Ono Pharmaceutical Co., Ltd (Ono). The lack of revenues in the first quarter of 2015 reflects the completed amortization associated with a technology transfer milestone payment. The Company does
not have any active collaborations, however it is eligible to receive potential future milestone payments under its agreement with Ono. |
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Total operating expenses for the first quarter of 2015 were $41.4 million, compared to $22.8 million for the first quarter of 2014. |
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Research and development (R&D) expenses were $36.0 million for the first quarter of 2015 compared to $20.0 million for the first quarter of 2014. The increase in R&D costs is primarily related to
increased external costs related to the Companys clinical development programs as well as increased personnel costs related to R&D staffing increases over the past 12 months. |
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General and administrative (G&A) expenses were $5.4 million for the first quarter of 2015, compared to $2.8 million for the first quarter of 2014. The increase in G&A expenses is primarily related to
the expansion of the Companys operating activities and is comprised of an increase in personnel costs related to additional headcount, additional stock-based compensation expense, and additional expenditures on outside services, including
consulting costs, legal and accounting fees, market research and insurance. |
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Net loss attributable to common shareholders was $40.0 million, or $1.29 per share, for the first quarter of 2015, compared to $21.5 million, or $1.01 per share, for the first quarter of 2014. Net loss for the first
quarter of 2015 included stock-based compensation expense of $3.8 million, compared to $1.8 million for the first quarter of 2014. |
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Receptos had $644.6 million in cash, cash equivalents and short term investments and approximately 33.0 million shares of common stock outstanding on a fully diluted basis as of March 31,
2015. |
Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
The Receptos management team will host a teleconference and webcast to discuss the first quarter 2015 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), participant code 27905354. 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, participant code 27905354.
About Receptos
Receptos is a biopharmaceutical
company developing therapeutic candidates for the treatment of immune and metabolic diseases. The Companys lead program, ozanimod, is a sphingosine 1-phosphate 1 and 5 receptor small molecule modulator in development for immune indications
including RMS and IBD. Patents supporting ozanimod were exclusively licensed to Receptos from The Scripps Research Institute (TSRI). The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for eosinophilic
esophagitis (EoE), an allergic/immune-mediated orphan disease, as well as pipeline, pre-clinical stage assets.
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. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the sufficiency of
the Companys financial resources 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 accomplish certain development goals (such
as the completion of clinical trials and availability of clinical trial results), and the safety, efficacy, projected development timeline and therapeutic and commercial potential for ozanimod (RPC1063), RPC 4046 and the GLP-1 positive allosteric
modulator program, constitute forward-looking statements. 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 Companys 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 Companys financial position and research and development programs are described in detail in the Companys SEC filings, including the Companys Annual Report on Form 10-K for the year
ended December 31, 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.
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Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
RECEPTOS, INC.
CONSOLIDATED FINANCIAL RESULTS
(In thousands, except per
share amounts)
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Three months ended March 31, |
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2015 |
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2014 |
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Collaborative revenue |
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$ |
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1,350 |
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Operating expenses: |
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Research and development |
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36,042 |
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20,007 |
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General and administrative |
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5,386 |
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2,759 |
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Total operating expenses |
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41,428 |
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22,766 |
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Loss from operations |
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(41,428 |
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(21,416 |
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Other income (expense) |
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301 |
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(84 |
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Foreign currency gain |
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786 |
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Net loss attributable to common stockholders |
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$ |
(40,341 |
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$ |
(21,500 |
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Net loss per common share, basic and diluted |
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$ |
(1.29 |
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$ |
(1.01 |
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Shares used to compute net loss per common share, basic and diluted |
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31,337 |
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21,195 |
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RECEPTOS, INC.
CONSOLIDATED BALANCE SHEET DATA
(IN THOUSANDS)
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As of March 31, |
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As of December 31, |
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2015 |
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2014 |
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Cash, cash equivalents and short-term investments |
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644,569 |
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671,929 |
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Working capital |
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611,093 |
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647,012 |
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Total assets |
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661,425 |
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678,007 |
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Total liabilities |
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47,346 |
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28,520 |
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Common stock and additional paid-in capital |
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865,041 |
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860,415 |
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Total stockholders equity |
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614,079 |
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649,487 |
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