This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding:
· Our future sales and product revenue, including geographic expansions,
possible retroactive price adjustments, and expectations of unit volumes or
other offsets to price reductions;
· Our manufacturing capacity, efficiency gains and work-in-process manufacturing
· The timing, scope and rate of patient enrollment for clinical trials;
· The development of possible line extensions and new products;
· Our ability to achieve and/or maintain compliance with laws and regulations;
· The timing of and/or receipt of
or other regulatory approvals, clearances, and/or reimbursement approvals of
current, new or potential products, and any limitations on such approvals;
· Our intention to seek patent protection for our products and processes, and to
protect our intellectual property;
· Our ability to effectively compete against current and future competitors;
· Negotiations with potential and existing partners, including our performance
under any of our existing and future distribution, license or supply
agreements, and our expectations with respect to sales and sales threshold
milestones pursuant to such agreements;
· The level of our revenue or sales in particular geographic areas and/or for
particular products, and the market share for any of our products;
· Our expectations of product revenue results in future quarters and for the
full year 2014; · Our current strategy, including our corporate objectives, research and development activities and collaboration activities;
· Our expectations regarding our orthobiologics products, including existing
products and expectations regarding new products, expanded uses of existing
products, new distribution partnerships and revenue growth;
· Our intention to increase our market share for orthobiologics products in
domestic and international markets or otherwise penetrate growing markets for
osteoarthritis of the knee and other joints;
· Our expectations regarding next generation orthobiologics product development,
clinical trials, regulatory approvals and commercial launches;
· Our and Bausch & Lomb's performance under the non-exclusive, three-year
contract for the supply of AMVISC® and AMVISC® Plus ophthalmic viscoelastic
products, our expectations regarding revenue from ophthalmic products, and the
impact that such agreement's expiration will have on our results of operations
going forward. · Our ability to commercialize AnikaViscTM and AnikaViscTM Plus and our expectations regarding such commercialization and the potential profits generated thereby;
· Our ability to license our aesthetics product to new distribution partners
domestically and outside the U.S.;
· Our ability, and the ability of our distribution partners, to market our
aesthetics dermatology product; and our expectations regarding the distribution and sales of our ELEVESSTM product and the timing thereof;
· Our expectations regarding development of aesthetics product line extensions;
· Our expectations regarding HYVISC® sales; · Our expectations regarding product gross margin; · Our expectations regarding CINGALTM, including the expense associated
therewith, the timing of, and our ability to obtain regulatory approvals for
· Our expectation for changes in operating expenses, including research and
development, and selling, general and administrative expenses;
· The rate at which we use cash, the amounts used and generated by operations,
and our expectations regarding the adequacy and usage of such cash;
· Our expectation for capital expenditures and future amounts of interest income
· Possible negotiations or re-negotiations with existing or new distribution or
collaboration partners; · Our ability to continue streamlining operations and improving our manufacturing capabilities;
· Our ability to obtain additional funds through equity or debt financings,
strategic alliances with corporate partners and other sources, to the extent
our current sources of funds are insufficient;
· Our ability to manage the operations of Anika S.r.l. as a company generating
· The strength of the economies in which the Company operates or will operate,
as well as the political stability of any of those geographic areas;
· Our ability to effectively prioritize the many research and development
· Our ability to expand the therapeutic applications of our existing products
and create new applications for our HA technology; · Our ability to obtain U.S. approval for orthopedic and other product
franchises of Anika S.r.l., including the timing and potential success of such
efforts, and to expand sales of these products in the U.S., including the
impact such efforts may have on our revenue; and
· Our ability to successfully defend the Company against lawsuits and claims,
and the uncertain financial impact such lawsuits and claims and related defense costs may have on the Company. Furthermore, additional statements identified by words such as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and which do not relate to historical matters, also identify forward-looking statements. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond our control, including those factors described in the section titled "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the year ended
December 31, 2013. These risks, uncertainties and other factors may cause our actual results, performance or achievement to be materially different from anticipated future results, performance or achievement, expressed or implied by the forward-looking statements. These forward-looking statements are based upon the current assumptions of our management and are only expectations of future results. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences, including those factors discussed herein and in the "Management's Discussion and Analysis of Financial Condition and Results of Operations" section of this Quarterly Report on Form 10-Q, as well as the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2013and in our press releases and other filings with the Securities and Exchange Commission. We undertake no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors of new information, future events or other changes. 13 --------------------------------------------------------------------------------
Anika Therapeutics, Inc.(together with its subsidiaries, " Anika," the "Company," "we," "us," or "our") develops, manufactures and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on hyaluronic acid ("HA"), a naturally occurring, biocompatible polymer found throughout the body. Due to its unique biophysical and biochemical properties, HA plays an important role in a number of physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural integrity of tissues, and the transport of molecules to and within cells. Anika'sproprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to therapeutic use. Our patented technologies chemically modify the HA molecule to allow for longer residence time in the body. Anika Therapeutics, Inc.'swholly-owned subsidiary, AnikaTherapeutics S.r.l., has over 20 products currently commercialized. These products are also all made from hyaluronic acid, based on two technologies: "HYAFF," which is a solid form of HA, and ACP gel, an autocross-linked polymer of HA. Both technologies are protected by an extensive portfolio of owned and licensed patents. We offer therapeutic products from these aforementioned technologies in the following areas: Anika Anika S.r.l. Orthobiologics X X Dermal Advanced wound care X Aesthetic dermatology X Surgical Anti-adhesion X X Ear, nose and throat care ("ENT") X Ophthalmic X Veterinary X
Please see Management's Discussion and Analysis of Financial Condition and Results of Operations-Management Overview (Item 7) to the Company's Annual Report on Form 10-K for the year ended
Research and Development
Anika'sresearch and development efforts primarily consist of the development of new medical applications for our HA-based technologies, the management of clinical trials and studies for certain product candidates, the preparation and processing of applications for regulatory approvals or clearances at all relevant stages of product development, and process development and scale-up manufacturing activities related to our existing and new products. Our development focus includes products for tissue protection, healing and repair. Our investment in R&D varies considerably depending on the number and size of clinical trials and studies underway. We anticipate that we will commit significant resources to research and development, including clinical trials, in the future. During the first quarter of 2014, the Company received FDAapproval of MONOVISC and resolved the patent lawsuit with Genzyme Corporation. The Company received a milestone payment of $17,500,000under the Mitek MONOVISC Agreement related to FDAapproval of MONOVISC and the successful resolution of the Genzyme patent litigation. As a result of the full delivery of our development obligations under this agreement, the Company also recognized the remaining balance of deferred revenue relating to the initial $2,500,000non-refundable up front payment. Both amounts were fully recognized as revenue during the three months ended March 31, 2014. A key product currently under development is CINGAL, which is based on our hyaluronic acid material with an added active therapeutic molecule designed to provide broad pain relief for a longer period of time. We have completed the formulation and biocompatibility studies of the product. During the second quarter of 2013, we commenced a multinational phase III clinical trial to obtain the clinical data necessary for a CE Mark submission and approval, and to support other product registrations including in the United States. Enrollment in the clinical trial was completed in February 2014, and we expect to be in a position to submit our CE Mark application by December 31, 2014, or shortly thereafter.
HYALOFAST is an innovative biodegradable matrix for human bone marrow mesenchymal stem cells used in connection with soft tissue regeneration. HYALOFAST received CE Mark approval in
The technologies obtained through our acquisition of Anika S.r.l. have enhanced our research and development capabilities, and our pipeline of product candidates. Anika S.r.l. has research and development programs for new products including HYALOFAST and HYALOSPINE, an adhesion prevention gel for use after spinal surgery. Our research and development efforts may not be successful in (1) developing our existing product candidates, (2) expanding the therapeutic applications of our existing products, or (3) resulting in new applications for our HA technology. There is also a risk that we may choose not to pursue development of potential product candidates. We also may not be able to obtain regulatory approval for any new applications we develop. 14 --------------------------------------------------------------------------------
Litigation and Other Legal Matters
July 7, 2010, Genzyme Corporation filed a complaint against the Company in the United States District Court for the District of Massachusettsseeking unspecified damages and equitable relief. The complaint alleges that the Company has infringed U.S. Patent No. 5,143,724 by manufacturing MONOVISC in the United Statesfor sale outside the United Statesand will infringe U.S. Patent Nos. 5,143,724 and 5,399,351 if the Company begins to manufacture and sell MONOVISC in the United States. On March 7, 2014Genzyme and the Company filed a joint motion to lift the stay in Genzyme's lawsuit against the Company and to dismiss with prejudice all of Genzyme's claims. On March 10, 2014, the District Court granted the motion to dismiss with prejudice all of Genzyme's claims against the Company and the case was terminated. We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations or cash flows.
Results of Operations
Three and Six Months Ended
June 30, 2014Compared to the Three and Six Months Ended June 30, 2013 Three Months Ended June 30, Six Months Ended June 30, 2014 2013 Inc/(Dec) 2014 2013 Inc/(Dec) Product revenue $ 21,267,156 $ 20,067,4076 % $ 35,618,561 $ 34,561,8963 %
Licensing, milestone and contract revenue 5,007,504 760,970
558 % 24,666,386 1,513,492 1530 % Total revenue 26,274,660 20,828,377 26 % 60,284,947 36,075,388 67 % Operating expenses: Cost of product revenue 5,332,913 6,311,332 (16 %) 9,693,932 11,152,502 (13 %) Research & development 1,873,158 1,829,052 2 % 4,160,873 3,411,962 22 % Selling, general & administrative 3,865,876 3,400,679 14 % 7,356,861 7,347,793 0 % Restructuring credits - (111,178 ) (100 %) - (246,785 ) (100 %) Total operating expenses 11,071,947 11,429,885 (3 %) 21,211,666 21,665,472 (2 %) Income from operations 15,202,713 9,398,492 62 % 39,073,281 14,409,916 171 % Interest income (expense), net 5,935 (36,381
) (116 %) 6,402 (75,939 ) (108 %) Income before income taxes
15,208,648 9,362,111 62 % 39,079,683 14,333,977 173 % Provision for income taxes 5,906,298 3,467,219 70 % 14,747,080 5,371,083 175 % Net income
$ 9,302,350 $ 5,894,89258 % $ 24,332,603 $ 8,962,894171 % Product gross profit $ 15,934,243 $ 13,756,07516 % $ 25,924,629 $ 23,409,39411 %
Product gross margin 75 % 69 % 73 % 68 % Product Revenue Product revenue for the quarter ended
June 30, 2014was $21,267,156, an increase of 6%, as compared to $20,067,407for the quarter ended June 30, 2013. Product revenue for the six-month period ended June 30, 2014was $35,618,561, an increase of 3%, as compared to $34,561,896for the six-month period ended June 30, 2013. For the three months ended June 30, 2014, increases in product revenue from our Orthobiologics and Veterinary franchises were partially offset by timing related decreases in revenue from our Dermal, Ophthalmic and Surgical products. The increases in the three and six-month periods ended June 30, 2014from the prior year periods was primarily driven by MONOVISC product sales increases both domestically and internationally. 15 --------------------------------------------------------------------------------
The following table presents product revenue by group for the three and six-month periods ended
Three Months Ended June 30, Increase (Decrease) 2014 2013 $ % Orthobiologics
$ 18,278,25416,506,226 $ 1,772,02811 % Dermal 348,961 557,059 (208,098 ) (37 %) Surgical 1,376,530 1,830,022 (453,492 ) (25 %) Ophthalmic 363,411 464,340 (100,929 ) (22 %) Veterinary 900,000 709,760 190,240 27 % $ 21,267,156 $ 20,067,407 $ 1,199,7496 % Six Months Ended June 30, Increase (Decrease) 2014 2013 $ % Orthobiologics $ 29,850,40427,789,773 $ 2,060,6317 % Dermal 537,612 798,643 (261,031 ) (33 %) Surgical 3,128,549 2,818,886 309,663 11 % Ophthalmic 571,996 1,392,798 (820,802 ) (59 %) Veterinary 1,530,000 1,761,796 (231,796 ) (13 %) $ 35,618,561 $ 34,561,896 $ 1,056,6653 % Orthobiologics Our orthobiologics franchise consists of our joint health and orthopedic products. Overall, sales increased 11% and 7% for the three and six-month periods ended June 30, 2014, as compared to the same periods in 2013. The growth in the second quarter of 2014 reflected revenue from MONOVISC sales in the U.S as a result of the product launch. We expect orthobiologics product revenue to increase in 2014 as compared to 2013, both domestically and internationally.
Our dermal franchise consists of advanced wound care products and aesthetic dermal fillers. In
July 2014, the Company entered nto a new agreement with Medline Industries Inc.to commercialize HYALOMATRIX in the U.S. on an exclusive basis through 2019. For the three and six month periods ended June 30, 2014, dermal product sales decreased 37% and 33%, respectively to $348,961and $537,612, as compared to the same periods in 2013. This decrease primarily reflects order timing by our distribution partners. Anika'sadvanced wound care products treat complex skin wounds ranging from burns to diabetic ulcers, with HYALOMATRIX and HYALOFILL as the lead products. For the full year 2014, we expect revenue from our dermal products to increase as compared to 2013.
Our surgical franchise consists of products used to prevent post-surgical adhesions in abdominal-pelvic, spinal, and ear, nose and throat ("ENT") disorders. Sales of our surgical products decreased 25% and increased 11% for the three and six-month periods ended
June 30, 2014to $1,376,530and $3,128,549, respectively, as compared to the same periods in 2013. The year-to-date increase of surgical product revenue was primarily due to strong demand for our HYALOBARRIER product from our European and Asian partners. For the full year 2014, we expect revenue from our surgical products to increase as compared to 2013. Ophthalmic Our ophthalmic franchise consists of HA viscoelastic products used in ophthalmic surgery. Ophthalmic product sales decreased 22% and 59% to $363,411and $571,996, respectively, for the three and six-month periods ended June 30, 2014, as compared to the same periods in 2013. The decrease was primarily attributable to Bausch & Lomb delaying its contractual minimum purchases until the fourth quarter of 2014. We expect the overall ophthalmic revenue to be lower in 2014, as compared to 2013, as a result of the terms of the current Bausch & Lomb supply agreement. B&L's current contract expires at the end of this year and will not be renewed. Given that the ophthalmic franchise is not part of our core business, and that it has been steadily diminishing for the past few years, we do not expect this event to have a material impact on our results going forward. 16 --------------------------------------------------------------------------------
Veterinary revenue from HYVISC increased by 27% to
$900,000and decreased by 13% to $1,530,000for the three and six-month periods ended June 30, 2014,respectively, as compared to the same periods in 2013. The variation for the three and six month- periods were primarily due to order timing by our distribution partner, Boehringer Ingelheim Vetmedica. We continue to look at other veterinary applications and opportunities to expand geographic territories.
Licensing, milestone and contract revenue
Licensing, milestone and contract revenue for the three and six-month periods ended
June 30, 2014was $5,007,504and $24,666,386, respectively, as compared to $760,970and $1,513,492for the same periods in 2013. Revenue for the quarter ended June 30, 2014included a $5,000,000milestone payment associated with our U.S. license agreement for MONOVISC. The year to date June 30, 2014increase in licensing, milestone and contract revenue included a $17,500,000milestone payment resulting from the resolution of the patent litigation with Genzyme and the FDAapproval of MONOVISC, and the recognition of an approximately $2,200,000remaining unamortized upfront payment previously received in December 2011. These payments are related to development obligations under the license agreement. The FDA'sapproval of our MONOVISC product during the quarter ended March 31, 2014completed the delivery of our development obligations under the license agreement, and resulted in the immediate recognition of the $17.5 millionmilestone payment, as well as the full recognition of prior deferred revenue in the first quarter of 2014. During the second quarter of 2014, a $5,000,000milestone payment associated with the first commercial sale of MONOVISC in the U.S. was earned, received, and recognized as revenue.
Product gross profit and margin
Product gross margin for the three and six-month periods ended
June 30, 2014was $15,934,243and $25,924,629, or 75% and 73% of the product revenue for each period, respectively. Product gross margin for the three and six-month periods ended June 30, 2013was $13,756,075and $23,409,394, or 69% and 68% of the product revenue for each period, respectively. The increase in product gross margin for the three and six-month periods ended June 30, 2014, as compared to the same periods in 2013, is attributable to a more favorable product mix, a material cost reduction, and continued efficiency gains at our Bedford, Massachusettsfacility. This quarter's product gross margin may not be indicative of the rest of the year due to dynamics including the future mix of our product sales, and other factors.
Research and development
Research and development expenses for the three and six-month periods ended
June 30, 2014were $1,873,158and $4,160,873, respectively, or 7% of total revenue for both periods. This primarily reflects the completion of patient enrollment in our phase III Cingal clinical trial during the first quarter of 2014 and on-going patient follow-up activities, as compared to trial start-up activities in the same periods last year. Research and development spending is expected to increase in future quarters as we further develop new products based on our existing technology assets.
Selling, general and administrative
Selling, general and administrative ("SG&A") expenses for the three and six-month periods ended
June 30, 2014were $3,865,876and $7,356,861, respectively, representing 15% and 12% of total revenue. SG&A expenses increased for both the three and six-month periods ending June 30, 2014, as compared to the same periods in 2013, primarly as a result of increases in headcount related costs, external professional fees, and corporate goverance costs. Included in the first quarter of 2013 were certain non-recurring external professional fees and personnel costs. We expect general and administrative expenses to increase in 2014, as compared to 2013, reflective of the support required to grow our business both domestically and internationally.
Provisions for income taxes were
$5,906,298and $14,747,080for the three and six-month periods ended June 30, 2014, based on effective tax rates of 39% and 38%, respectively. Provisions for income taxes were $3,467,219and $5,371,083for the three and six-month periods ended June 30, 2013, respectively, based on effective tax rates of 37% for both periods. The increase in income taxes over the three-month period ended June 30, 2014was primarily due to increased net income, which reflected $5,000,000in milestone and contract revenue associated with our U.S. license agreement for MONOVISC. The increase in income taxes over the six-month period ended June 30, 2014was primarily due to increased net income, which reflected $24,652,778in milestone and contract revenue associated with our U.S. license agreement for MONOVISC. The increase in the effective tax rate for each of the periods ended 2014, as compared to the same periods ended in 2013, was driven primarily by the unavailability of the federal R&D tax credit in 2014, due to its expiration on December 31, 2013, and a relative decrease to certain estimated production activities deduction 17 -------------------------------------------------------------------------------- The Company files income tax returns in the U.S. on a federal basis, in certain U.S. states, and in Italy. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. Our filings from 2010 through the present tax year remain subject to examination by the IRSand other taxing authorities for U.S. federal and state tax purposes. Our filings from 2009 through the present tax year remain subject to examination by the appropriate governmental authorities in Italy. In connection with the preparation of the financial statements, the Company performed an analysis to ascertain if it was more likely than not that it would be able to utilize, in future periods, the net deferred tax assets associated with its net operating loss carryforward. We have concluded that the positive evidence outweighs the negative evidence and, thus, those deferred tax assets are realizable on a "more likely than not" basis. As such, we have not recorded a valuation allowance at June 30, 2014or December 31, 2013.
Liquidity and Capital Resources
We require cash to fund our operating expenses and capital expenditures. We expect that our requirements for cash to fund operations will increase as the scope of our operations expands. Historically, we have generated positive cash flow from operations, which together with our available cash and investments, have met our cash requirements. Cash and cash equivalents totaled approximately
$84.9 millionand $63.3 millionat June 30, 2014and December 31, 2013, respectively. Working capital totaled approximately $112.2 millionat June 30, 2014and $85.3 millionat December 31, 2013. The Company believes it has adequate financial resources to support its business for the next twelve months. Cash provided by operating activities was $20,319,099for the six months ended June 30, 2014, as compared to cash provided by operating activities of $9,632,926for the same period in the prior year. This increase in cash provided by operations was due primarily to a total of $22.5 millionmilestone payments received under the Mitek MONOVISC Agreement. This cash inflow is partially offset by an increase in inventory due to anticipated future sales demand. Cash used in investing activities was $677,358for the six months ended June 30, 2014as compared to cash provided by investing activities of $136,914for the same period in 2013. The increase in cash used in investing activities is the result of higher capital expenditures in 2014 as compared to the same period in 2013, as well as the proceeds received from the sale of property and equipment in the prior year period relating to our reorganization of Anika S.r.l. in the beginning of 2013. Cash provided by financing activities was $1,838,733for the six months ended June 30, 2014, as compared to cash provided by financing activities of $335,471for the same period in 2013. The increase in cash provided by financing activities in the current year's period is attributable to the increased tax benefits received in regards to employees' exercise of stock options during the first six months of 2014, partially offset by minimum tax withholdings on share-based awards.
Critical Accounting Estimates
During the six months ended
June 30, 2014, the Company received FDAapproval of MONOVISC and the patent litigation related to MONOVISC was also resolved. As a result, the Company shortened the estimate of the performance period related to the Mitek MONOVISC Agreement. There were no other significant changes in our critical accounting estimates during the six months ended June 30, 2014, as compared to the estimates disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013.
Recent Accounting Pronouncements
June 2014, the Financial Accounting Standards Board("FASB") issued Accounting Standards Update ("ASU") No. 2014-12, "Compensation - Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period", which requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. Thus, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The new guidance is effective for the Company beginning January 1, 2016. Early adoption is permitted. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. 18 -------------------------------------------------------------------------------- In May 2014, the FASB issued ASU No. 2014-09, "Revenue from Contracts with Customers." ASU 2014-09 supersedes the revenue recognition requirements in "Topic 605, Revenue Recognition" and requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective retrospectively for annual or interim reporting periods beginning after December 15, 2016, with early application not permitted. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. In April 2014, the FASB issued ASU No. 2014-08, "Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity." ASU 2014-08 provides a narrower definition of discontinued operations than that provided under existing U.S. GAAP. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, which disposal represents a strategic shift that has, or will have, a major effect on the reporting entity's operations and financial results, should be reported in the financial statements as a discontinued operation. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. ASU 2014-08 is effective prospectively for disposals (or classifications as held for disposal) of components of an entity that occur in annual or interim periods beginning after December 15, 2014. The Company does not expect the adoption of ASU 2014-08 to have a material impact on its consolidated financial statements.
Contractual Obligations and Other Commercial Commitments
We have had no material changes outside the ordinary course to our contractual obligations disclosed in our Annual Report on Form 10-K for the period ended
December 31, 2013. To the extent that funds generated from our operations, together with our existing capital resources, are insufficient to meet future requirements, we will be required to obtain additional funds through equity or debt financings, strategic alliances with corporate partners and others, or through other sources. No assurance can be given that any additional financing will be made available to us or will be available on acceptable terms should such a need arise.
Off-balance Sheet Arrangements
The Company does not use special purpose entities or other off-balance sheet financing techniques, except for operating leases, that we believe have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity or capital resources.