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): November 14, 2012
NEOSTEM, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) | 001-33650 (Commission File Number) | 22-2343568 (IRS Employer Identification No.) |
420 Lexington Avenue, Suite 350, New York, New York 10170
(Address of Principal Executive Offices)(Zip Code)
(212) 584-4180
Registrant's Telephone Number
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 (see General Instruction A.2. below):
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | 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 November 14, 2012, NeoStem, Inc., a Delaware corporation (the “Company” or “NeoStem”), issued a press release relating to, among other things, the results of the Company's third fiscal quarter ended September 30, 2012. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 2.02 by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the 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 Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
NeoStem, Inc. intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and other conferences a slide presentation. The slide presentation is accessible on NeoStem’s website at www.neostem.com and is attached hereto as Exhibit 99.2. NeoStem undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing.
Forward Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1 hereto, contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions, although some forward-looking statements are expressed differently. Forward-looking statements represent the Company's management's judgment regarding future events. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. All statement other than statements of historical fact included in the Current Report on Form 8-K are forward-looking statements. The Company cannot guarantee the accuracy of the forward-looking statements, and you should be aware that the Company's actual results could differ materially from those contained in the forward-looking statements due to a number of factors, including the statements under "Risk Factors" contained in the Company's reports filed with the Securities and Exchange Commission.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated November 14, 2012* | |
99.2 | Slide presentation of NeoStem, Inc. dated November 2012* | |
*Exhibit 99.1 and Exhibit 99.2 are furnished as part of this Current Report on Form 8-K.
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.
NEOSTEM, INC. | ||||
By: | /s/ Catherine M. Vaczy | |||
Name: | Catherine M. Vaczy, Esq. | |||
Title: | Vice President and General Counsel | |||
Dated: November 14, 2012
Investor Presentation NYSE MKT: NBS November 2012
Forward-Looking Statements This presentation includes “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from anticipated results, performance or achievements expressed or implied by such forward-looking statements. When used in this Quarterly Report on Form 10-Q, statements that are not statements of current or historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “plan,” “intend,” “may,” “will,” “expect,” “believe,” “could,” “anticipate,” “estimate,” or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. Additionally, statements regarding our ability to successfully develop, integrate and grow the business, including with regard to our research and development efforts in respect of AMR-001 and other cell therapeutics, our adult stem cell collection, processing and storage business, contract manufacturing and process development of cellular based medicines, the future of regenerative medicine and the role of stem cells in that future, the future use of stem cells as a treatment option and the role of VSEL TM Technology in that future and the potential revenue growth of such businesses, are forward-looking statements. Our future operating results are dependent upon many factors and our further development is highly dependent on future medical and research developments and market acceptance, which is outside our control. Forward-looking statements, including with respect to the successful execution of the Company's strategy, may not be realized due to a variety of factors and we cannot guarantee their accuracy or that our expectations about future events will prove to be correct. Such factors include, without limitation, (i) our ability to manage the business despite operating losses and cash outflows; (ii) our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for AMR-001, and the commercialization of the relevant technology; (iii) our ability to build the management and human resources and infrastructure necessary to support the growth of the business; (iv) our ability to integrate our acquired businesses successfully and grow such acquired businesses as anticipated, including expanding our PCT business into Europe; (v) whether a large global market is established for our cellular-based products and services and our ability to capture a share of this market; (vi) competitive factors and developments beyond our control; (vii) scientific and medical developments beyond our control; (viii) our ability to obtain appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of the business; (ix) whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; (x) whether any potential strategic benefits of various licensing transactions will be realized and whether any potential benefits from the acquisition of these licensed technologies will be realized; (xi) the results of our development activities, including the timing, enrollment, outcome and/or results of any clinical trials; and (xii) the other risk factors discussed in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission (the SEC”) which are available for review at www.sec.gov under “Search for Company Filings.” All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. 2
3 Cell Therapy Development Commercial Operations U.S. East Coast U.S. West Coast Europe* *2013
2006 2007 2008 2009 2010 2011 2012 2013 Acquired Stem Cell Technologies, Inc. Acquired CBH (51% of Erye) Acquired Acquired Divested Commercial and European Expansion Began 5 year partnership with Vatican for adult stem cell education Phase III Medical Acquired NeoStem, Inc. NYSE MKT: NBS Transaction Timeline 80% Acquired $3.8 $7.9 $2.9 $15.7 $33.2 $21.2 $32.4 4 Through Nov. 12, 2012 Accessed $117 million
• Strong and nimble management team • Access to Capital o Over $100M raised to date o Secured $15m of non-dilutive capital • Pipeline of Cell therapies in development • Expanding IP portfolio • State-of-the Art contract manufacturing and research organization (East and West Coast operations) The Ingredients for Success 5
• More than 10 million AMI patients worldwide • 20% are STEMI putting patients at risk of a progressive deterioration in heart muscle function that leads to: o Arrhythmias o Recurrent myocardial infarction o Congestive heart failure o Premature death • According to AHA, the prognosis for STEMI patients is unchanged over recent decades Clear Unmet Medical Need for AMI Patients 6 AHA 2012 Statistical Update, Circulation 2012
A consequence of inadequate perfusion (microvascular insufficiency) is apoptosis and progressive cardiomyocyte loss in the peri-infarct zone, leading to infarct expansion. The Peri-Infarct Zone Becomes the Infarct 7
Hypoxic/ischemic myocardium in peri-infarct zone signals need for perfusion (and cells will soon undergo apoptosis) CD34+CXCR4+ angiogenic & anti- apoptotic (via akt) cells could migrate to SDF-1 but don’t respond to cardiac signal The Body’s Natural Repair Mechanism Is Not Sufficient After Acute Myocardial Infarction 8
AMR-001 Brings Repair System to the Heart in Order to Preserve Function CD34⁺CXCR4+ Cells are a natural repair mechanism 9
Phase 1 Trial Design for AMR-001 Indication Post-AMI with LVEF ≤50% and wall motion abnormality in the myocardium of the IRA Primary Endpoint Safety in post-AMI patients Other Endpoints RTSS* (Perfusion); LVEF; ESV; SDF mobility Key Inclusion Criteria Confirmation of ST Elevation MI; Ejection fraction ≤ 50% 96 hours post stenting Dosing Frequency Single dose Groups and Randomization 3 dose cohorts (5, 10, 15 million cells, randomized 1:1) Number of Subjects N=31 Number of Sites 4 Geography United States Trial Duration 6 months Day 4: CMR Day 1: Ventriculography Day 6-10: Injection into the IRA Day 5-8: 6-8 Hour Cell Separation Process 10
Phase 1 Study Results: AMR-001 Preserves Function • Myocardial Perfusion Improved: o Dose-related improvement of perfusion via CD34+/ SDF-1 mobile cells (SPECT measured RTSS) • Myocardial Tissue Preserved: o Dose-related improvement in tissue preserved via CD34+/ SDF-1 mobile cells (% infarct size by CMR) • Threshold Dose Identified: o Dose ≥ 10 million cells significantly improves perfusion Quyyumi AA et al 2011, American Heart Journal; 161(1) 98-105 11
Phase 1 Study Results: Increasing Doses of CD34+/ SDF-1 Mobile Cells Reduced Ischemic Tissue Effect measured as RTSS via SPECT-Sestamibi Quyyumi AA et al 2011, American Heart Journal; 161(1) 98-105 Y= Δ RTSS, X = Dose of SDF1 mobile CD34 cells 12
Phase 1 Study Results: Increasing Doses of CD34+/ SDF-1 Mobile Cells Reduced Infarct Size Effect measured by reduced percent infarct size by CMR Quyyumi AA et al 2011, American Heart Journal; 161(1) 98-105 Y= Δ Infract % LV Mass, X = Dose of SDF1 mobile CD34 cells 13
Delivery of CD34+ Cell Therapy Improves Blood Flow and Oxygen Delivery While Preserving Heart Function AMR-001 (CD34+ cells) delivered via coronary artery to hypoxic heart tissue New blood vessel growth starts within days to preserve cells and restore heart function 14
PreSERVE-AMI Phase 2 Study 15 Indication Post-AMI preservation of cardiac function Design Randomized (1:1) Primary Endpoint Change in cardiac perfusion (RTSS by SPECT) from baseline to 6 months Other Endpoints Secondary endpoints to determine preservation of cardiac function and clinical events: CMR to measure LVEF, LVESV, LVEDV, regional myocardial strain, infarct/peri-infarct regional wall motion abnormalities, and infarct size (baseline and 6 months) Quality of Life measures: (KCCQ & SAQ) Reduction in cumulative MACE and other adverse clinical cardiac events at 6, 12, 18, 24, and 36 months Treatment Single dose. Minimum dose for release >10MM cells Number of Subjects 160 patients
Anticipated Time Line to Commercialization 2011 2012 2013 2014 2015 2016 2017 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 6 mo. MACE 12 mo. MACE 18 mo. MACE Phase 2 Patient Enrollment 36 mo. MACE FDA Meeting Phase 2 US and EU Phase 3 Enrollment 18 mo. MACE Phase 3 Trial Sites = 50 Patients = 160 Trial Sites = 140 Patients ~ 800 6 mo. MACE 12 mo. MACE BLA Submission 2017 Phase II Data Presentation • Early pharmacoeconomic studies show estimated cost range of $25-36,000 16
Additional Potential Indications for AMR-001 • AMR-001 platform can be applied to other conditions caused by underlying ischemia o Chronic myocardial ischemia post-AMI o Congestive heart failure o Critical limb ischemia o Ischemic brain injury • Broad and growing patent portfolio supports cardiac and other ischemic conditions o AMR-001: Composition of matter patent (2028) o U.S. 7,794,705: Issued 9/14/2010. Indication: Cardiac: Post AMI early and late o U.S. 8,088,370: Issued 1/3/2012. Indication: Any vascular injury: Post vascular insufficiency 17
T-reg Cells to Restore Immune Balance • Partnership with Becton Dickinson, which owns 20% of Athelos • Immune-mediated diseases, such as GVHD, autoimmune disorders and allergic conditions, are a result of an imbalance between T-effector cells and T-regulatory cells (T-reg) • T-reg therapy represents a novel approach for restoring immune balance by enhancing T-regulatory cell number and function • Phase 1 work is ongoing globally under several independent physician INDs, including Dr. P. Trzonkowski, Dr. Jeffrey Bluestone and Dr. Rob Negrin, results of which will inform NeoStem’s future clinical direction 1) Chai, Jian-Guo et al, Journal of Immunology 2008; 180;858-869 18
VSELs – Adult Stem Cells heart neuron pancreas VSEL™ • Very small embryonic-like (VSELsTM) stem cells are believed to be naturally pluripotent • Animal models have demonstrated that highly enriched human VSELs are able to integrate, differentiate and potentially regenerate • Indications being explored include macular degeneration, osteoporosis, cardiac, acute radiation syndrome, and wounds • Pre-clinical work financed largely by grants and DOD funding TM 19
• NeoStem develops therapies for chronic unmet medical needs around a strong IP portfolio • NeoStem’s patent estate includes: o Amorcyte – 3 patents granted and multiple patents pending o Athelos – 20 patents granted/3 pending patents o VSEL Technology – 8 patent families pending o Composition of matter and methods claims o Geographic breadth of filings includes North America, Europe, Asia, Australia, Israel and South Africa Intellectual Property 20
Progenitor Cell Therapy Contract Development and Manufacturing Organization Manufacturing Experience • Numerous cell types • Various cell processes • Several therapeutic applications • Immunotherapy • Hematopoietic replacement • Tissue repair 13 Year Proven Track Record 21
Capacity Mountain View, California (25,000 ft2) ISO Class 7 / Class 10,000 suites Allendale, New Jersey (30,000 ft2) ISO Class 7 / Class 10,000 suites ISO Class 6 / Class 1,000 suite 22
• Large and small companies in the cell therapy space outsource services for all or part of their manufacturing needs: • Currently operates 55,000 square feet of North American facilities with cGMP manufacturing capacity – Enables lower costs for internal cell therapy development – Cash flow that can be reinvested toward growth and internal development activities • Establish early partnering relationships with goals of commercial manufacturing, equity participation and back-end royalties • Expansion plans underway for commercial manufacturing in the US and growth into Europe Business Model & Capabilities 23
24 Key Financial Metrics (as of November 13, 2012) Revenue1 $11.6m (nine months ended September 30, 2012) Cash Position2 $7.9m (as of September 30, 2012) Additional Cash3 $12.0m Total Stock and Equivalent Shares Common Shares 159.4m Options 21.7m (avg. option exercise price of $1.29) Warrants 55.3m (avg. warrant exercise price of $1.59) 1 Revenues from continuing operations 2 Includes $5.4m cash and cash equivalents and $2.5m cash held in escrow as security for Preferred Series E Obligations (cash held in escrow subsequently used in the redemption of the Preferred Series E obligation in October 2012) 3 Cash proceeds received in the fourth quarter from Erye sale, equity sales, and warrant exercises
Why Invest Now? Exciting Proprietary Cell Therapy Pipeline • Phase 2 AMR-001 PreSERVE trial enrollment underway and data read-out expected in late 2013 o Patient accrual is underway • Strong IP portfolio in a rapidly growing industry o $50 billion is spent annually on regenerative medicine o Industry projected to increase 15% annually (compounded) Revenue Generating Contract Development and Manufacturing Business • Revenue side of the business averaging >$10 million annually • Validation of approach through agreements with “Who’s Who” of cell therapy companies o Clients: Baxter, Sotio, Coronado, PrimaBio, ImmunoCellular, etc. Leadership That Can Execute • Strong management team with decades of regulatory experience • Successfully completed five M&A transactions • Obtained $3 million in DOD and NIH funding to advance cell therapy products • Submitted an additional $13 million in grant applications Known Presence and Strong Performance on the Street • Consistent liquidity and strong technical indicators • Respected analyst coverage: Cowen, JMP, WBB, Chardan 25
Contact Information NeoStem, Inc. NYSE MKT: NBS www.neostem.com Robin Smith, MD, MBA Chairman & CEO Phone: (212) 584-4174 Email: rsmith@neostem.com v4 26
Exhibit 99.1
NeoStem Announces Quarterly Results and Business Update
NEW YORK, Nov. 14, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company") today announced third quarter results and provided a business update. NeoStem is emerging as a market leader in the fast growing cell therapy market. The Company's multifaceted business strategy combines a state-of-the-art contract development and manufacturing organization (CDMO) with a medically important cell therapy product development program providing for near- and long-term revenue growth opportunities.
Business Highlights
Revenues from continuing operations grew 98% for the nine months ended September 30, 2012 compared to the prior year period.
NeoStem is continuing to enroll patients into the PreSERVE Phase 2 clinical trial in the U.S. for post AMI (acute myocardial infarction) patients and anticipates completing enrollment in 2013 with 6 months initial data readout at the end of 2013. Peak annual worldwide sales of AMR-001 for this indication could be over $1 billion based upon anticipated market penetration of the qualified target patient population.
On November 13, 2012, NeoStem completed the divestiture of Erye, for which it received a total of $12,280,000 in cash and removes from the Company's balance sheet over $30 million in short and long-term debt obligations. Erye also returns 1,040,000 shares representing approximately 0.7% of the Company's outstanding common stock, 1,170,000 stock options representing approximately 5.1% of the Company's outstanding options and 640,000 warrants to purchase common stock held by Erye representing approximately 1.1% of the Company's outstanding warrants.
As of September 30, 2012, the Company had cash of $7.9 million (see reconciliation below) and has received an additional $12.0 million subsequent to September 30, 2012 from the sale of its ownership in Erye, equity transactions and warrant exercises. In October 2012, the Company completed the redemption of all outstanding shares of its Series E 7% Senior Convertible Preferred Stock.
Results of Continuing Operations for the Three Months and Nine Months Ended September 30, 2012
The Erye divestiture allows the Company to hone its focus on its cell therapy clinical development programs and the PCT CDMO commercial business. Continuing operations consist of the Company's cellular therapy business in the United States.
Revenues from continuing operations for the three and nine months ended September 30, 2012 were $4.4 million and $11.6 million, respectively, compared to $2.2 million and $5.8 million for the same periods in 2011. The increase in revenue, representing a 98% revenue growth for the nine months ended September 30, 2012 compared to the prior year period, was primarily driven by clinical service revenues in the Company's PCT subsidiary, and reflected an increased overall visibility and penetration of PCT into the cell therapy marketplace, along with a general increase in the development of autologous cell therapies in the United States due to enhanced investment and expanded marketing programs in 2011 and 2012.
PCT's industry role is to be a problem solver (consultant), implementation expert and cGMP manufacturing service provider from product discovery to commercialization for product developers. In its thirteen year history, PCT has supported over one hundred regenerative medicine companies and NeoStem anticipates growth in the United States and abroad by expansion into Europe.
Net loss from continuing operations attributable to NeoStem common shareholder interests for the three and nine months ended September 30, 2012 was $8.5 million and $23.5 million, respectively, or $0.06 and $0.18 per share, compared to $6.5 million and $26.7 million, or $0.07 and $0.32 per share for the three and nine months ended September 30, 2011. The Company's loss from continuing operations for the nine months ended September 30, 2012, excluding non-cash charges, was $15.6 million (see reconciliation below). Management believes the Erye divestiture should reduce legal and financial reporting cost going forward.
Summary
The opportunity for existing and new NeoStem shareholders is substantial. In the midst of global economic uncertainty, NeoStem has assembled a multifaceted business plan that can drive top revenue growth through its PCT CDMO business while investing in dynamic cell therapy development programs. The Company's service business and pipeline of proprietary cell therapy products work synergistically, giving NeoStem a competitive advantage that is unique in the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a dynamic patent and patent pending intellectual property portfolio, NeoStem is well-positioned for future success. Company management will continue to seek business opportunities that will strengthen the Company and looks forward to achieving success for its investors with the goal of achieving the level of one of the world's top tier biopharmaceutical companies.
GAAP to Non-GAAP Reconciliations | |||
Nine Months Net Loss from Continuing Operations Excluding Non-Cash Charges Reconciliation | |||
Loss from continuing operations | $ | (23,765,160 | ) |
Common stock, stock options and warrants issued | 5,471,166 | ||
Depreciation and amortization | 1,160,596 | ||
Amortization of preferred stock discount and issuance cost | 1,195,217 | ||
Changes in fair value of derivative liability | (46,910 | ) | |
Loss on disposal of assets | 12,964 | ||
Bad debt expense | 328,003 | ||
Net Loss from Continuing Operations Excluding Non-Cash Charges | $ | (15,644,124 | ) |
Cash as of September 30, 2012 Reconciliation | |||
Cash and cash equivalents | $ | 5,390,611 | |
Cash held in escrow as security for the Series E 7% Convertible Preferred Stock | 2,500,000 | ||
Cash as of September 30, 2012 | $ | 7,890,611 | |
For more information on NeoStem, please visit www.neostem.com.
Forward-Looking Statements for NeoStem, Inc.
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, including with respect to successful completion of clinical trials, FDA approval and commercial launch of AMR-001 and other cell therapeutics under development, the size of the market for such products, the company's competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, the Company's ability to successfully grow its CDMO business, including expanding into Europe, the efficacy of protection from its patent portfolio of its cell therapy products under development, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including, but not limited to those matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update is forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
CONTACT:
Trout Group
Gitanjali Jain Ogawa, Vice President
Phone: +1-646-378-2949
Fax: +1-646-378-2949
Email: gogawa@troutgroup.com