| • QUARTERLY REPORT • CERTIFICATION • CERTIFICATION • CERTIFICATION • CERTIFICATION • EX-101.INS • EX-101.SCH • EX-101.CAL • EX-101.LAB • EX-101.PRE • EX-101.DEF | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-Q
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STELLAR PHARMACEUTICALS INC.
(Exact name of small business issuer as specified in its charter)
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57 Martin Street, Milton, Ontario, Canada L9T 2R1
(Address of Principal Executive Office) (Zip Code)
(519) 434-1540
(Issuer’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
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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 of 1934 during the preceding 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
The number of outstanding common shares, no par value, of the Registrant at: March 31, 2012: 39,610,042
TABLE OF CONTENTS
2
PART 1 – CONSOLIDATED FINANCIAL STATEMETNS
STELLAR PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
(Expressed in Canadian dollars)
(Unaudited)
See accompanying notes to the condensed consolidated interim financial statements.
3
STELLAR PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS AND DEFICIT
(Expressed in Canadian dollars)
(Unaudited)
See accompanying notes to the condensed consolidated interim financial statements.
4
STELLAR PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Expressed in Canadian dollars)
(Unaudited)
See accompanying notes to the condensed consolidated interim financial statements.
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
The Company has patents pending of $112,190 at March 31, 2012 (December 31, 2011 - $121,087) and a licensing agreement of $7,664,000 (December 31, 2011 - $7,664,000) not currently being amortized.
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
In connection with a private placement offering in October 2010, the Company granted 1,500,000 warrants to the participants, each exercisable into one Common Share as follows: 500,000 at US$1.50 ($1.50), 500,000 at US$2.00 ($2.00) and 500,000 at US$2.50 ($2.50) each for a period of 18 months, ending on April 8, 2012. The exercise price of the 1,500,000 warrants is denominated in US dollars while the Company’s functional and reporting currency is the Canadian dollar. As a result, the fair value of the warrants fluctuates based on the current stock price, volatility, the risk free interest rate, time remaining until expiry and changes in the exchange rate between the US and Canadian dollar. The fair value of the warrant liability at the date of grant was $206,774 and was estimated using the Black-Scholes option pricing model, based on the following assumptions: expected dividend yield of 0%; expected volatility of 85%; risk free interest rate of 1.45%; and expected term of 1.5 years.
ASC 815 “Derivatives and Hedging” (formerly referred to as SFAS133) indicates that warrants with exercise prices denominated in a different currency than an entity’s functional currency should not be classified as equity. As a result, these warrants have been treated as derivatives and recorded as liabilities carried at their fair value, with period-to-period changes in the fair value recorded as a gain or loss in the condensed consolidated interim statements of operations and comprehensive loss and deficit. The Company treated the compensation warrants as a liability upon their issuance.
As at March 31, 2012, the fair value of the warrant liability of $nil (December 31, 2011 - $2,543) was estimated using the Black-Scholes option pricing model based on the following assumptions: expected dividend yield of 0% expected volatility of 56% risk-free interest rate of 0.89% and expected term of 8 days. On April 6, 2012, these warrants were extended until April 8, 2013.
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
The treasury stock method assumes that proceeds received upon the exercise of all warrants and options outstanding in the period are used to repurchase the common shares at the average share price during the period. The diluted earnings per share is not computed when the effect of such calculation is anti-dilutive.
The following table sets forth the computation of loss earnings per share:
Changes in non-cash balances related to operations are as follows:
During the three month period ended March 31, 2012, there were no interest or taxes paid (2011 – $nil).
The Company has royalty, licensing and manufacturing agreements that have remained in effect for the Company during the quarter. In addition, there were no material changes to lease agreement during the period.
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
On June 30, 2008, Tribute signed a Sales, Marketing and Distribution Agreement with Actavis Group PTC ehf (“Actavis”) to perform certain sales, marketing, distribution, finance and other general management services in Canada in connection with the importation, marketing, sales and distribution of Bezalip® SR and Soriatane® (the “Products”). On January 1, 2010, a first amendment was signed with Actavis to grant Tribute the right and obligation to more actively market and promote the Products in Canada. On March 31, 2011, a second amendment was signed with Actavis that extended the term of the agreement, modified the terms of the agreement and increased Tribute’s responsibilities to include the day-to-day management of regulatory affairs, pharmacovigilance and medical information relating to the Products. Tribute pays Actavis a sales and distribution fee up to an annual base-line net sales forecast plus an incremental fee for incremental net sales above the base-line. Tribute has agreed to a marketing budget for the first three years of not less than $3,750,000. On May 4, 2011, Tribute signed a Product Development and Profit Share Agreement with Actavis to develop, obtain regulatory approval of and market Bezalip SR in the USA. The Company shall pay US$5,000,000 to Actavis within 30 days of receipt of the regulatory approval to market Bezalip SR in the USA.
On November 9, 2010, Tribute signed a License Agreement with Nautilus Neurosciences, Inc. (“Nautilus”) for the exclusive rights to develop, register, promote, manufacture, use, market, distribute and sell Cambia® in Canada. The payments under this agreement include: a) US$250,000 ($255,820) upfront payment to Nautilus upon the closing of this agreement; and b) Other milestone payments include: US$750,000 upon the earlier of the first commercial sale or six months after approval by Health Canada, US$250,000 on annual net sales of US$2,500,000, US$500,000 on annual net sales of US$5,000,000, US$750,000 on annual net sales of US$7,500,000, US$1,000,000 on annual net sales of US$10,000,000, US$1,500,000 on annual net sales of US$15,000,000 and US$2,000,000 on annual net sales of US$20,000,000. Royalties are payable at rates ranging from 22.5-25.0% of net sales. The term of the agreement is 15 years.
Cambia received approval by Health Canada on March 20, 2012 and subsequently, the Company issued 2,000,000 common shares to the Tribute shareholders, as per the Share Purchase Agreement dated December 1, 2011. As noted above, a future milestone payment of US$750,000 is due, subject to certain conditions, upon the earlier of the first commercial sale of the product, or six months after approval.
On December 30, 2011, Stellar signed a License Agreement to commercialize MycoVa in Canada. As of March 31, 2012 this product has not been filed with Health Canada and to-date no upfront payments have been paid. Within 10 days of execution of a manufacturing agreement, Stellar shall pay an up-front license fee of $200,000. Upon Health Canada approval Stellar shall pay $400,000. Sales milestones payments of $250,000 each are based on the achievement of aggregate net sales in increments of $5,000,000. Royalties are payable at rates ranging from 20% to 25% of net sales.
(b) Executive Termination Agreements
The Company currently has employment agreements with the provision of termination and change of control benefits with officers and executives of the Company. The agreements for the officers and executives provide that in the event that any of their employment is terminated during the initial term by the Company for any reason other than just cause or death, by the Company because of disability, by the officer or executive for good reason, or in the event of termination of the officer’s or executive’s employment by the Company or by the officer or executive for any reason or a change in control, the officer or executive shall be entitled to the balance of the remuneration owing for the remainder of the initial term equal to $1,794,167 as of March 31, 2012 (December 31, 2011 - $2,160,000) or if a change of control occurs subsequent to the initial term, while the officer or executive is employed on an indefinite basis, a lump sum payment equal to $1,520,000 (based on current base salary).
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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STELLAR PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
The Company currently sells its own products and is in-licensing other products in Canada. In addition, revenues include products which the Company out-licenses in Europe, the Caribbean, Austria, Germany, Italy, Lebanon, Kuwait, Malaysia, Portugal, Romania, Spain, South Korea Turkey and the United Arab Emirates. The continuing operations reflected in the unaudited condensed consolidated interim statements of operations and comprehensive loss and deficit includes Stellar’s activity in these markets.
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This document was prepared on May 11, 2012 and should be read in conjunction with the December 31, 2011 consolidated financial statements of Stellar Pharmaceuticals Inc. ("Stellar" or the "Company"). All amounts are stated in Canadian dollars and have been rounded to the nearest one hundredth dollar.
Forward-looking Statements
Readers are cautioned that actual results may differ materially from the results projected in any "forward-looking" statements (within the meaning of Section 27A of the Exchange Act (as defined below)) included in this report, which involve a number of risks or uncertainties. Forward-looking statements are statements that are not historical facts, and include statements regarding the Company’s planned research and development programs, anticipated future losses and gains, revenues and market shares, planned clinical trials, expected future expenditures, the Company’s intention to raise new financing, sufficiency of working capital for continued operations, and other statements regarding anticipated future events and the Company’s anticipated future performance. Forward-looking statements generally can be identified by the words "expected", "intends", "anticipates", "feels", "continues", "planned", "plans", "potential", "with a view to", and similar expressions or variations thereon, or that events or conditions "will", "may", "could" or "should" occur, or comparable terminology referring to future events or results.
The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. The Company assumes no responsibility to update the information contained herein.
Critical Accounting Policies
There have been no material changes to the Company’s Critical Accounting Policies and Assumptions filed in the Company’s 2011 Annual Report on the Form 10-K.
Recent Accounting Pronouncements
On January 1, 2012, the Company adopted the accounting standards as set out below. Adoption of these standards did not have a material impact on the Company’s financial statements.
In June 2011, the FASB issued an accounting standards update that eliminates the option to present components of other comprehensive income as part of the statement of changes in equity and requires an entity to present items of net income and other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. This guidance also required an entity to present on the face of the consolidated financial statements, reclassification adjustments from other comprehensive income to net income. This guidance was effective for fiscal years beginning after December 15, 2011, which is the Company’s 2012 fiscal year. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
In May 2011, the FASB issued an accounting standards update that clarified and amended the existing fair value measurement and disclosure requirements. This guidance was effective prospectively for interim and annual periods beginning after December 15, 2011, which is the Company’s 2012 fiscal year. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
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In September 2011, the FASB issued new accounting guidance that simplified goodwill impairment tests. The new guidance states that a “qualitative” assessment may be performed to determine whether further impairment testing is necessary. This guidance was effective for periods beginning on or after December 15, 2011, which is the Company’s 2012 fiscal year. The adoption of this guidance did not have a material impact on the Company’s financial position or results of operations.
Overview
Stellar is an emerging Canadian specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada. The Company targets several therapeutic areas in Canada, but has a particular interest in products for the treatment of pain, urology, dermatology and endocrinology/cardiology. Stellar also sells Uracyst® and NeoVisc® internationally through a number of strategic partnerships. On December 1, 2011, the Company acquired Tribute Pharmaceuticals Canada Ltd. and Tribute Pharma Canada Inc. (together herein referred to as “Tribute”), creating a North American specialty pharmaceutical company. As a result, Stellar has gained access to a portfolio of existing products, as well as certain rights to the future development and distribution of therapeutic products within the Canadian marketplace.
Stellar’s current portfolio of assets includes the following nine products: NeoVisc®, NeoVisc® Single Dose, Uracyst®, BladderChek®, Bezalip® SR, Soriatane®, Cambia®, Daraprim®, and MycoVa™. Each of these products has received regulatory approval in Canada, with the exception of MycoVa. On May 11, 2012, Stellar’s licensor for MycoVa®, Apricus Biosciences announced that Health Canada has granted them a pre-NDS (New Drug Submission) meeting to take place in Ottawa on July 18, 2012.
Stellar markets its products in Canada through its own sales force and currently has licensing agreements for the distribution of select products in 27 countries, and continues to expand this “footprint”. The Company’s focus on business development is twofold: utilizing in-licensing and out-licensing for immediate impact on its revenue stream, as well as product development for future growth and stability.
The Company is now actively engaged on numerous fronts to grow its business through business development activities. There remain a number of key geographical territories globally where NeoVisc and Uracyst are not currently being marketed. In particular, both of these products remain available for the United States. Stellar intends to focus its efforts to find partners to market its brands in international territories where the Company does not have a direct commercial presence.
Stellar met with the FDA in the United States in March 2012 to discuss the US approval of Bezalip SR. Bezalip SR is approved in over 40 countries world-wide but not in the United States. Stellar recognizes that the US rights to develop Bezalip SR is an important asset to the Company in the largest market in the world, and will do everything it can to maximize the opportunity.
Stellar’s management team has prior experience in senior management positions with other pharmaceutical companies. This team has extensive business development experience and has completed numerous prior product acquisitions, licensing and product re-formulation transactions. The senior management at Stellar managed companies with sales in excess of USD$300 million in the U.S. and over CDN$150 million in Canada. The Stellar management team also has experience in product launches in Canada.
Results of Operations for the Three Month Period Ended, March 31, 2012
For the three month period ended March 31, 2012, total revenues from all sources increased by 357% to $2,900,000, compared to $634,000 in the same period during 2011. The increase is mainly due to licensed domestic product net sales of $1,906,000, compared to $nil in the prior year as a result of the acquisition of Tribute. In addition, there was an increase of 101.9% in international product sales to $520,000 for the three months ending March 31, 2012 compared to $257,500 for the same period during 2011, as well as an increase in domestic product sales for the three month period ending March 31, 2012 of 26.9%.
The Company’s net loss for the first quarter of 2012 was $626,300 compared to a loss of $302,900 during the same period in 2011, mainly due to the increased cost base of Tribute, which is investing significantly in sales and marketing to grow its existing products, preparing to launch a new product plus increased business development activity.
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Gross Profit and Cost of Products Sold
Gross profit for the first quarter of 2012 was $1,232,800, up 166.5%, compared to a gross profit of $462,646 in the same period in 2011. The improved gross profit in 2012 was due to the licensed domestic product net sales, less associated cost of these sales, representing a gross profit of $559,000. Excluding this, gross profit would have been $673,800, still an increase of $211,000 compared to the same period of the prior year.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three month period ended March 31, 2012 was $2,019,000, compared to $704,100 for the same period in 2011 for an increase of $1,314,900 or 186.8%. The increase in these costs is due primarily to the acquisition of Tribute with the first quarter selling, general and administrative expenses of $875,100 being comprised of sales and marketing expenses, Cambia regulatory and pre-launch expenses, regulatory expenses for Bezalip SR in the US and Stellar integration expenses. Additionally, there was $158,500 in stock-based compensation expense recorded in the first quarter of 2012, compared to $63,700 for the same period of the prior year.
Interest and Other Income
Interest and other income during the three month period ended March 31, 2012 was $3,500 (2011 - $3,500). These amounts include interest received on short-term investments for both 2012 and 2011. In 2012, interest earned on the Company’s short-term investments was an average of 1.08% compared to an average of 1.10% in 2011.
Summary of Quarterly Results
Liquidity and Capital Resources
The Company’s cash and cash equivalents position amounted to $1,016,000 at March 31, 2012 compared with $2,228,000 at December 31, 2011.
At March 31, 2012, the Company did not have any outstanding indebtedness.
Off-Balance Sheet Arrangements
The Company does not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which are established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
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Related Party Transactions
Fees were paid to LMT Financial Inc. ("LMT") (a company beneficially owned by Mr. Arnold Tenney, a director and former interim officer of the Company, and his spouse) for consulting services. For the three month period ended, March 31, 2012, the Company recorded and paid an aggregate of $37,500 to LMT (2011 - $41,700) which has been recorded as selling, general and administrative expense in the condensed consolidated interim statements of operations and comprehensive loss and deficit.
During the period ending March 31, 2012 the Company paid $nil for legal services (2011 – $9,900) to a law firm in which one of the directors of the Company is a partner, which have been recorded as selling, general and administrative expense on the condensed consolidated interim statements of operations and comprehensive loss and deficit.
Significant Customers
During the three month period ended March 31, 2012, the Company had two significant customers that represented 52.8% of product sales two major wholesalers) (2011 – 39.1% (one major wholesaler – 27.7%; and one international customer – 11.4%). The Company believes that its relationships with these customers are satisfactory.
Capital Stock
The Company has authorized an unlimited number of common shares, without par value. There are no other classes of shares issued. During the three month period ended March 31, 2012, 2,000,000 common shares (2011 – nil) were issued by the Company. As of the date of this report, the Company has 39,610,042 common shares issued and outstanding.
As of the date of this report, the Company had 3,122,952 common share options outstanding with an average exercise price of $0.65 per option.
Subsequent Events
On April 5, 2012, the Company extended the expiration date of the Company’s outstanding Series 1 warrants, Series 2 warrants and Series 3 warrants, one year to April 8, 2013. The warrants, collectively exercisable into an aggregate of 1,500,000 common shares of the Company, were originally issued to the holders thereof on October 8, 2010 as part of the Company’s non-brokered private placement. No other terms of the warrants were amended or modified.
On May 11, 2012, Stellar closed a US$6 million Loan and Security Agreement with MidCap Financial LLC. The term loan will mature May 11, 2015 and will be advanced in two tranches with the first tranche of US$3.5 million funded on closing. The second tranche of US$2.5 million is available until March 31, 2013 subject to a raise by Stellar of at least $6 million or in conjunction with an acquisition or an in-licensing transaction. The facility has a 36 month term with the first 6 months being interest only at a rate of Libor plus 7%. MidCap has been granted a warrant to purchase common shares of Stellar equal to 8% of the amount borrowed under the term loan divided by the exercise price. The warrant associated with the first tranche will have an exercise price equivalent to the 20 day average closing price prior to the first advance. The warrant will be exercisable for 5 years from the date of issuance.
Bloom Burton & Co. from Toronto, Ontario, Canada acted as Stellar’s agent on the above mentioned transaction and is entitled to a fee and warrants in the amount of 4% of the amounts actually borrowed.
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Stellar is a smaller reporting company (as defined by Rule 12b-2 of the Exchange Act) (as defined below) and is not required to provide the information required under this Item.
(a) Evaluation of Disclosure Controls and Procedures
Based on an evaluation of the Company’s disclosure controls and procedures performed by the Company’s Chief Executive Officer and Chief Financial Officer as of the end of the period covered by this report, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective.
As used herein, “disclosure controls and procedures” means controls and other procedures of the Company that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the rules and forms issued by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its Chief Executive Officer and its Chief Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
(b) Changes in Internal Control Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Additional Information
We make available free of charge through our website, www.stellarpharma.com, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) of the Exchange Act, as soon as reasonably practicable after those reports are filed with or furnished to the Securities and Exchange Commission (“SEC”).
The public may read any of the items we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information about the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site that contains reports, proxy and information statements, and other information regarding the Company and other issuers that file electronically with the SEC at http://www.sec.gov.
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STELLAR PHARMACEUTICALS INC.
PART II – OTHER INFORMATION
None.
Stellar is a smaller reporting company (as defined by Rule 12b-2 of the Exchange Act) and is not required to provide information required under this Item.
None.
None.
None.
None.
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