UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-QSB [X] QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES ACT OF 1934 For the quarterly period ended MAY 31, 2006 ------------ Commission File Number 0-12305 ------- REPRO-MED SYSTEMS, INC. ----------------------- (Exact name of registrant as specified in its charter) NEW YORK 13-3044880 -------- ---------- (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 24 CARPENTER ROAD, CHESTER, NY 10918 ------------------------------ ----- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (845) 469-2042 -------------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ( X ) No ( ) Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Class Outstanding at May 31, 2006 ----- --------------------------- Common stock, $.01 par value 30,413,286 Shares REPRO-MED SYSTEMS, INC. TABLE OF CONTENTS PART I PAGE ---- ITEM 1. Financial Statements Balance Sheet (Unaudited) - May 31, 2006 and February 28, 2006 (Audited) ....................................... 3 Statements of Operations (Unaudited) - for the three-months ending May 31, 2006 and May 31, 2005 .............................. 4 Statements of Cash Flow (Unaudited) - for the three months ending May 31, 2006 and May 31, 2005 .............................. 5 Notes to Unaudited Financial Statements ........................... 6 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations ..................... 7 PART II ITEM 1. Legal Proceedings ................................................. 11 ITEM 2. Changes in Securities ............................................. 11 ITEM 3. Defaults Upon Senior Securities ................................... 11 ITEM 4. Submission of Matters to a Vote of Security Holders ............... 11 ITEM 5. Other Information ................................................. 11 ITEM 6. Exhibits and Reports on Form 8-K .................................. 11 2 REPRO-MED SYSTEMS, INC. BALANCE SHEET MAY 31, FEBRUARY 28, 2006 2006 ASSETS (UNAUDITED) (AUDITED) - ------ ----------- ----------- CURRENT ASSETS - -------------- Cash & Cash Equivalents .................... $ 3,796 $ 26,753 Accounts Receivable, net ................... 104,746 147,579 Inventory .................................. 371,987 347,392 Prepaid Expenses ........................... 31,654 28,182 ----------- ----------- TOTAL CURRENT ASSETS ........................... 512,183 549,906 PROPERTY & EQUIPMENT, NET ...................... 250,738 268,096 OTHER ASSETS - ------------ Patents, net of amortization .............. 33,453 35,214 Goodwill, net of amortization ............. 8,879 8,969 Security Deposits ......................... 27,652 27,652 ----------- ----------- TOTAL OTHER ASSETS ............................. 69,984 71,835 ----------- ----------- TOTAL ASSETS ................................... $ 832,905 $ 889,837 =========== =========== LIABILITIES & STOCKHOLDERS' EQUITY - ---------------------------------- CURRENT LIABILITIES - ------------------- Accounts Payable ........................... $ 317,778 $ 284,095 Notes Payable to Related Parties ........... 54,535 6,834 Accrued Expenses ........................... 53,866 46,172 Note Payable to Bank ....................... 198,553 198,553 Accrued Payroll and Related Taxes .......... 14,663 17,030 Accrued Interest ........................... 45,040 42,663 Accrued Preferred Stock Dividends .......... 32,000 32,000 Current Portion Capital Lease Obligations .. 6,917 9,437 ----------- ----------- TOTAL CURRENT LIABILITIES .................. 723,352 636,784 =========== =========== OTHER LIABILITIES - ----------------- Capital Lease Obligations, Less Current Portion ....................... - 616 Deferred Capital Gain Income ............... 286,636 292,256 Long-Term Debt - Notes Payable ............. 530,000 530,000 ----------- ----------- TOTAL LIABILITIES .............................. 1,539,988 1,459,656 ----------- ----------- STOCKHOLDERS' EQUITY - -------------------- Preferred Stock, 8% Cumulative, liquidation value $100,000 Par Value, $0.01 Authorization 2,000,000 Shares Issued & Outstanding 10,000 Shares @ May 31, 2006 and February 28, 2006 ....... 100 100 Common Stock, $.01 Par Value, Authorized 50,000,000 Shares, 30,413,286 shares and 29,012,286 shares issued and outstanding at May 31, 2006 and February 28, 2006, Respectively .......... 304,133 290,123 Additional Paid-in Capital ................. 2,502,288 2,446,248 Accumulated Deficit ........................ (3,371,604) (3,164,290) ----------- ----------- (565,083) (427,819) Less Treasury Stock, 2,275,000 shares at May 31, 2006 and February 28, 2006 ....... (142,000) (142,000) ----------- ----------- TOTAL STOCKHOLDERS' EQUITY (DEFICT) ........... (707,083) (569,819) ----------- ----------- TOTAL LIABILITIES & STOCKHOLDER'EQUITY ......... $ 832,905 $ 889,837 =========== =========== See Accompanying Notes to Financial Statements 3 REPRO-MED SYSTEMS, INC. STATEMENTS OF OPERATIONS UNAUDITED FOR THE 3 MONTHS ENDED ------------------------------- MAY 31, 2006 MAY 31, 2005 ------------ ------------ SALES - ----- Net Sales ................................ $ 347,725 $ 382,302 COSTS AND EXPENSES - ------------------ Cost of Goods Sold ..................... 150,310 178,657 Selling, General & Administrative Expenses ......... 285,939 261,097 Research and Development ............... 10,065 10,961 Stock-Based Compensation ............... 70,050 41,250 Depreciation and Amortization .......... 19,213 20,104 ------------ ------------ TOTAL COSTS AND EXPENSES ................. 535,577 512,069 ------------ ------------ INCOME (LOSS) FROM OPERATIONS ............ (187,852) (129,767) Non-Operating Income (Expense) Interest (Expense) ..................... (19,462) (17,773) Interest & Other Income ................ - 1,615 ------------ ------------ (19,462) (16,158) ------------ ------------ NET LOSS ................................. (207,314) (145,925) ------------ ------------ INCOME (LOSS) PER COMMON SHARE Basic and Diluted ...................... $ (0.01) $ (0.01) Average Common Shares Outstanding ........ 29,012,286 24,299,011 ============ ============ See Accompanying Notes to Financial Statements 4 REPRO-MED SYSTEMS, INC. STATEMENTS OF CASH FLOWS UNAUDITED FOR THE THREE MONTHS ENDED -------------------------- MAY 31, MAY 31, 2006 2005 --------- --------- CASH FLOWS FROM OPERATING ACTIVITIES Net Income (Loss) ................................ $(207,314) $(145,925) Adjustments to reconcile net loss to cash used in operating activities: Stock-Based Compensation ....................... 70,050 41,250 Depreciation and Amortization .................. 19,213 20,104 Capital Gain - Building Lease .................. (5,620) (5,619) Decrease (Increase) in Accounts Receivable ..... 42,833 10,510 Decrease (Increase) in Inventory ............... (24,595) 14,288 Decrease (Increase) in Prepaid Expenses ........ (3,476) 11,569 Decrease (Increase) in Accounts Payable ........ 33,683 (2,986) Decrease (increase) in Accrued Expenses ........ 7,704 (29,693) --------- --------- NET CASH (USED IN) OPERATIONS .................... (67,522) (86,502) --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES Capital Expenditures ........................... - (5,709) --------- --------- NET CASH USED IN INVESTING ACTIVITIES ............ - (5,709) CASH FLOW PROVIDED BY FINANCING ACTIVITIES Notes Payable - President and Others ............. 47,701 80,000 Payments, Increased Obligations on Capitalized Leases .......................... (3,136) (8,095) --------- --------- NET CASH PROVIDED BY FINANCING ACTIVITIES ........ 44,565 71,905 --------- --------- NET (DECREASE) INCREASE IN CASH .................. (22,957) (20,306) Cash and Cash Equivalents, beginning of period ... 26,753 37,330 --------- --------- Cash and Cash Equivalents, end of period ......... $ 3,796 $ 17,024 ========= ========= SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Interest ....................................... $ 19,462 $ 14,497 See Accompanying Notes to Financial Statements 5 REPRO-MED SYSTEMS, INC. NOTES TO THE FINANCIAL STATEMENTS UNAUDITED BASIS OF PRESENTATION The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial statements and with instructions to Form 10-QSB. Accordingly, they do not include all of the information and disclosures required for annual financial statements. These financial statements should be read in conjunction with the financial statements and related footnotes for the year ended February 28, 2006 included in the Form 10-KSB for the year then ended. In the opinion of the Company's management, all adjustments (consisting of normal recurring accruals) necessary to present fairly the Company's financial position as of May 31, 2006 and the results of operations and cash flows for the three month period ended May 31, 2006 and 2005 have been included. The results of operations for the three-month period ended May 31, 2006, are not necessarily indicative of the results to be expected for the full year. For further information, refer to the financial statements and footnotes thereto included in the Company's Form 10-KSB as filed with the Securities and Exchange Commission for the year ended February 28, 2006. STOCKHOLDERS' EQUITY/NOTES PAYABLE In connection with the Company's convertible notes, the Company is obligated to issue four shares of its common stock each year for each dollar of principal borrowed. As of May 31, the Company is obligated to issue an additional 1,401,000 shares for previously executed note agreements. Such shares have been considered as issued for purposes of financial reporting. GOING CONCERN As shown in the accompanying financial statements, the Company incurred a net loss of $207,314 during the three months ended May 31, 2006 and has an accumulated deficit of $3,371,604. Additionally, for the three months ended May 31, 2006, the Company had a negative working capital of $211,169. The Company is seeking to raise additional working capital through debt or equity channels and is working with outside distributors to increase the market share in the European and U.S. markets. However, even if the Company does raise capital through debt or equity channels or increase its sales through new strategies, there can be no assurances that the net proceeds of the capital raised or the revenue generated from the new marketing strategies will be sufficient to enable it to develop business to a level where it will generate profits and cash flows from operations. These matters raise substantial doubt about the Company's ability to continue as a going concern. However, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern. Related Party Loan During the quarter ended May 31, 2006, the President and Chief Executive officer lent the company $50,000 for operating expenses which will be repaid from receivable collections. 6 PART I ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This Quarterly Report on Form10-QSB contains certain "forward-looking" statements as that term is defined in the federal securities laws. Generally these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of managements plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. The events described in forward-looking statements contained in this Quarterly Report may not occur. The words "may," "will," "expect," "believe," "anticipate," "project," "plan," "intend," "estimate," and "continue," and their opposites and similar expressions are intended to identify forward-looking statements. We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond our control, that may influence the accuracy of the statements and the projections upon which the statements are based. Factors which may affect our results include, but are not limited to, the risks and uncertainties discussed in Item 6 of this Annual Report under "Factors That May Affect Future Results and Financial Condition". Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. Our actual results, performance and achievements could differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise. THREE MONTHS ENDED MAY 31, 2006 AND 2005 - ---------------------------------------- Sales of the FREEDOM60 Syringe Infusion System and related accessories increased 5.0% in the quarter ending May 31, 2006, as compared to the same period in 2005. We also experienced a 5.0% increase in revenues from non-core products (Gyneco, Osbon). Our revenues from the veterinary market, which consists of an OEM contract as well as sales of final products, increased 18.0%. Revenues in this market were $28,000 in the first quarter of this year, compared to $23,000 in 2005. However, sales of the RES-Q-VAC and accessories declined 22% quarter over quarter. This more than offset our revenue increases in other product lines. As a result, total sales for the first quarter declined 9.1% to $347,725 compared to $382,302 in 2005. Over 100% (or $33,656) of the total sales decline occurred in international markets, concentrated in Europe. Gross profit (Net Sales less Cost of Goods Sold) increased from 53.2% of net sales in 2005 to 56.8% in 2006 due, in part, to better inventory controls and management of fixed overhead expenses such as rent, utilities and insurance that are partially allocated to Cost of Goods Sold. Selling, general and administrative expense increased 9.5% ($24,842) to $285,939 in 2006 from $261,097 in 2005 reflecting, in part, an increased sales and marketing payroll and increased spending on sales and marketing efforts including mailings, trade shows and associated travel. Research and development expenses decreased slightly by $896, or 8%, from 2005 to 2006. This change was principally due to cost controls. Depreciation and amortization expense decreased slightly by $891 period over period as the amount of equipment reaching the end of its depreciable life exceeded capital purchases. Interest expense increased 9.5%, period over period, as a result of an in the prime lending rate, to which the interest rates for our promissory note program and bank line of credit are tied. 7 The Other Income category was primarily partial reimbursement from a job training program for production payroll expenses incurred and expensed in FY 2005. Net Loss increased by $61,389 from a loss of $145,925 in the quarter ended May 31, 2005 to a loss of $207,314 in the quarter ending May 31, 2006 due primarily to the allocation during this quarter of a full year of stock-based compensation (a non-cash expense)which increased from $41,250 during the quarter ended May 31, 2005 to $70,050, and a decrease in sales during the quarter. RES-Q-VAC - --------- The RES-Q-VAC(R) Emergency Airway Suction System, is a lightweight, portable, hand-operated suction device that removes fluids from a patient's airway by attaching the RES-Q-VAC(R) pump to various proprietary sterile and non-sterile single-use catheters sized for adult and pediatric suctioning. The one-hand operation makes it extremely effective and the product is generally found in emergency vehicles, hospitals and wherever portable aspiration is a necessity, including backup support for powered suction systems. The disposable features of the RES-Q-VAC(R) reduce the risk of contaminating the technician from HIV or SARS when suctioning a patient or during post treatment cleanup. All of the parts that connect to the pump are disposable. A critical component and advantage of the RES-Q-VAC(R) is the Full Stop Protection(R), (FSP(R)) a recently patented filtering system that both prevents leakage and over-flow of the aspirated fluids, even at full capacity, and traps all air and fluid borne pathogens and potentially infectious materials within the sealable container. This protects users from potential exposure to disease and contamination. The Full Stop Protection(R) meets the requirement of the Occupational Safety and Health Administration as described below. The Company has received a letter from OSHA confirming that the RES-Q-VAC(R) with the Full Stop Protection(R) falls under the engineering controls of the Bloodborne Pathogen regulation and that the Products use would fulfill the regulatory requirements. OSHA 29CFR 1910.1030 - Occupational Exposure to Bloodborne Pathogens requires that employers of "...emergency medical technicians, paramedics, and other emergency medical service providers; fire fighters, law enforcement personnel, and correctional officers... must consider and implement devices that are appropriate [to contain bloodborne pathogens], commercially available and effective." These first responders risk exposure to serious disease, and the employers may risk OSHA violations and lawsuits if they fail to consider protective measures such as Repro-Med's Full Stop Protection(R) for RES-Q-VAC(R). The Company has received a letter from OSHA indicating the RES-Q-VAC(R) meets the intent of this regulation. On April 29, 2003, the Centers for Disease Control issued additional guidelines for the control of SARS (Sudden Acute Respiratory Syndrome) which requires all suction systems to have filtration equivalent to a HEPA filter to prevent the spread of this disease. At the current time, we believe that the RES-Q-VAC(R) with Full Stop Protection(R) is the only portable device to comply with the CDC directives. We have also added new sturdier connectors to our pediatric catheters, which allow them to connect directly to the adult containers with FSP. These connectors allow pediatric suctioning with the benefit of the full protection FSP device as well as with sterile catheters. These improved features come at a lower cost for the user, and a more compact kit for easier transport. Many infants are born with contagious diseases and the new system eliminates this concern among paramedics during an emergency delivery. The adult large bore yankuer is also fitted with an improved connector, for easier changeability and convenience. We have begun upgrading our RES-Q-VAC distribution channels by selecting key distributors to work with as master distribution outlets. The domestic emergency medical market has softened due to a decrease in Federal reimbursement to state and city regional areas. We have concluded that we can have more effective market penetration with major master distributors who will have much greater sales volume and be able to better support our products. 8 We consolidated international RES-Q-VAC distribution, as well as our single point distribution in the UK. We are now providing direct support to our UK favored partners such as 24 hour deliver in the local currency. We also have master distribution in Norway, Sweden, Denmark, Iceland, Finland, Estonia, Latvia, and Lithuania. We are working towards single-point distribution in each country, where possible. We believe that one main distributor will be more predisposed to advertising, promotion, and building the product franchise in each market. In return, we will be able work more closely with the distributors and be able to hold them accountable for the sales in each region. We have continued our major sales efforts into the nursing home market for the RES-Q-VAC. The features of Full Stop Protection to meet OSHA requirements, sterile catheters, and the ability of RES-Q-VAC to work during extended power outages, have created a receptive market, especially in regions which recently have had major power outages, such as Florida with last years hurricanes and the blackout in the Northeast. Patients on ventilators, tracheotomy patients, elderly with swallowing disorders, stroke, heart attack, choke victims--all may need prompt effective suctioning wherever they are and for whom RES-Q-VAC may be life saving. This includes locations such as dining rooms, recreations areas, transportation and outdoor activities, among others. In the first quarter we retained a marketing and sales consulting group to assist the Company in its sales efforts. We have continued our direct mail and telephone marketing program to introduce RES-Q-VAC to the nursing home market and now the hospital market. We also conducted discussions with nursing home chains, hospitals and distributors in this market. We plan to continue the mail and telemarketing campaign to the greatest extent possible with our resources. We are focusing our greatest efforts to introduce the RES-Q-VAC into specific areas of hospitals, including crash carts, respiratory therapy and other departments. The non-battery, non-electric feature of the RES-Q-VAC appeals to hospitals which wish to reduce or avoid the costs associated with maintaining battery operated equipment in reliable, working order. FREEDOM60 - --------- The FREEDOM60(R) Syringe Infusion Pump is designed for ambulatory medication infusions. Ambulatory infusion pumps are most prevalent in the home care market. Other potential applications for the FREEDOM60(R) are pain control, the infusion of specialized drugs such as IgG, and chemotherapy. The home infusion therapy market is comprised of approximately 4,500 sites of service, including local and national organizations, hospital-affiliated organizations, and national home infusion organizations, and produces approximately $4.5 Billion in revenue annually (Ref: www.nhianet.org). With insurance reimbursement in a severe decline, there is a tremendous need for a low-cost, effective alternative to electronic and expensive disposable IV administration devices for the home care and nursing home market. The FREEDOM60(R) provides a high-quality delivery to the patient at costs similar to gravity and is targeted for the home health care industry, patient emergency transportation, and for any time a low-cost infusion is required. For the home care patient, FREEDOM60(R) is an easy-to-use lightweight mechanical pump using a 60cc syringe, completely portable, cost effective and maintenance free, with no batteries to replace and no cumbersome IV pole. For the infusion professional, FREEDOM60(R) delivers precise infusion rates and uniform flow profiles providing consistent transfer of medication. A Form 510(k) Premarket Notification for initial design of the FREEDOM60(R) as a Class II device was approved by the FDA in May 1994. The Company also markets the FREEDOM60(R)-FM, an enhanced version of the FREEDOM60(R) which contains an electronic flow monitor system that provides occlusion and end of infusion alarm. This product is directed at nursing homes, hospitals and pediatric ambulatory applications where alarms are generally required for nursing acceptance. Nurses also appreciate being able to visualize the drug volume by reading the scale on the syringe. 9 We have expanded the use of the FREEDOM60(R) to cover most antibiotics including the widely used and somewhat difficult to administer vancomycin. We have also found a following for FREEDOM60(R) for use in treating thalissemia with the drug desferal. In Europe we experienced success in using the FREEDOM60(R) for pain control, specifically post-operative epidural pain administration. Our European market also uses the FREEDOM60(R) for chemotherapy. We believe there is a new market for the FREEDOM60(R) for use in Primary Immune Deficiency, injecting immune globulin (IgG) under the skin as a subcutaneous administration. This method has provided patients with vastly improved quality of life with much fewer unpleasant side effects over the traditional intravenous route. The FREEDOM60(R) is an ideal system for this administration since the patient is able to self-medicate at home, the pump is easily configured for this application, and the FREEDOM60(R) is the lowest cost infusion system available in a heavily cost constrained market. TRADE SHOWS In May 1st-3rd, 2006, we exhibited the RES-Q-VAC at the ASPAN show in Orlando, FL where we introduced the RES-Q-VAC into the hospital market through the American Society of Perianesthesia Nurses. In the opinion of many attendees, the RES-Q-VAC could save many lives in the hospital environment, and we received over 125 leads from this show. Subsequently, in June we exhibited at Ambex in the United Kingdom for the RES-Q-VAC in support of our network of distributors in the British Isles. Our Director of International sales, working at one of our favored UK distributor's booth had the opportunity to meet with many RES-Q-VAC users as well as other international distributors. We have structured a depot in the UK to better support our sales and marketing into the UK and throughout Europe. We have begun to further explore new markets in the UK such as hospitals, nursing homes, veterinary, and dental. LIQUIDITY AND CAPITAL RESOURCES - During June 2000, we negotiated a $200,000 line of credit with M&T Bank that is guaranteed by the President and one of the directors. As of May 31, 2005, $198,553 has been advanced on the line of credit. In accordance with the agreement, the line of credit was to be renewed or paid off by June 30, 2001. We have received a verbal continuance from the bank through June 30, 2003. We have not received a demand for repayment of the loan and continue to make interest payments. Commencing in mid-February 2004, we started raising capital from a promissory note and stock offering and raised a total of $432,000 to date. This five year promissory note pays 2% over prime plus four share of common stock per year for every year the loan is in place. Our efforts to enter new markets and expand existing sales channels are capital-intensive. Access to capital markets for these efforts has been important in the past, and will continue to be vital as we seek to fully implement our marketing plans and work toward achieving a positive cash-flow position. We continue to pursue capital investment through debt or equity to increase our marketing and sales efforts, and to enhance our existing products and add to product lines. 10 PART II - OTHER INFORMATION - --------------------------- ITEM 1. LEGAL PROCEEDINGS The Company is neither a party to any material litigation, nor to the knowledge of the officers and directors of the Company, is there any other material litigation threatened against the Company. ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS None ITEM 3. DEFAULTS UPON SENIOR SECURITIES None ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matters were submitted to a vote of security holders of the Company during the quarter ended May 31, 2006. ITEM 5. OTHER INFORMATION None ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits 31.1 Certification of Chief Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certification of Chief Executive Officer and Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (b) Reports on Form 8-K None SIGNATURES Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934 the Registrant has duly caused this report to be signed on its behalf by the undersigned; thereunto duly authorized. REPRO-MED SYSTEMS, INC. /s/ Andrew I. Sealfon July 21, 2006 - --------------------- Andrew I. Sealfon, President, Treasurer, Chairman of the Board, Director, and Chief Executive Officer 11