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New words:
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Removed:
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Financial report summary
?Competition
ThermoGenesis • Integra LifeSciences • BioCardia • Adynxx • Zimmer Biomet • Nuvasive • Athersys, Inc / New • MiMedx • Cellular Biomedicine • ArrogeneRisks
- A significant delay in consummating or a failure to consummate the Transaction could have a material adverse effect on the price of our common stock and our operating results.
- Expenses related to the proposed Transaction are significant and will adversely affect our operating results.
- We are subject to business uncertainties and contractual restrictions while the Transaction is pending, which could adversely affect our business.
- Uncertainties associated with the Transaction may cause a loss of management and other key employees and disrupt our business relationships, which could adversely affect our business.
- Our operating results may fluctuate significantly as a result of a variety of factors, many of which are outside of our control.
- We have a history of operating losses and may not achieve or sustain profitability.
- We continue to expand our sales and marketing capabilities, and there can be no assurance that these efforts will result in significant increases in sales.
- We may have difficulty managing growth in our business, which could have a material adverse effect on our business, financial condition, and results of operations.
- Our revenues depend on obtaining coverage and adequate reimbursement from public and private insurers and health systems.
- Our products may have higher costs than more traditional products, due to the higher cost and complexity associated with their research, development and production, and the complexity associated with their distribution. This higher cost and complexity can make it more difficult to obtain adequate coverage and reimbursement.
- To continue our commercial expansion, we must convince more physicians that our products are appropriate alternatives to traditional methods and products and that our products should be used in their procedures.
- Some product development programs are based on novel technologies, which are inherently risky.
- We depend on key personnel.
- We are in a highly competitive and evolving field and face competition from well‑established tissue product manufacturers as well as new market entrants.
- Our products could become obsolete due to rapid technological change.
- Many of our competitors have greater resources or capabilities than we have, or may succeed in developing new or better products more quickly than we do.
- Our products are derived from human tissue and therefore have the potential for disease transmission.
- Ethical, legal, and other concerns surrounding the use of human tissue may negatively affect public perception of us or our products, or may result in increased scrutiny of our products and product candidates from a regulatory approval perspective, thereby reducing demand for our products, restricting our ability to market our products or adversely affecting the market price for our common stock.
- Our dependence upon human tissue necessary to produce our products may impact our ability to produce these products on a large scale.
- We may not be able to process our products in sufficient quantities to meet market demand or expand our market for the products.
- We use or may use third parties to help us develop, manufacture, market, and/or distribute our products, and our business may be impaired if our third‑party relationships are unsuccessful.
- We also rely upon third parties for services and raw materials needed for the manufacture and testing of our products.
- We distribute products through distribution arrangements that sometimes involve the consignment of inventory to third parties, which results in additional risk and uncertainty as to the viability of consigned inventory, inventory accounting, and tax consequences.
- We have no control over whether third parties with whom we contract can comply with applicable regulatory requirements.
- In addition to costs incurred in product development and management of the reimbursement processes, we will incur additional operating expenses in connection with the expansion of our business.
- Our future capital needs are uncertain and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all.
- If our manufacturing and storage facility is damaged or destroyed, our business and prospects would be negatively affected.
- The use of our products in human subjects may expose us to product liability claims, and we may not be able to obtain adequate insurance.
- We may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation and disrupt our business.
- We and our distributor sales representatives must comply with U.S. federal and state fraud and abuse laws, including anti‑kickback and false claims laws and equivalent foreign rules.
- A significant portion of our revenues and accounts receivable come from government accounts.
- Changes in internal purchasing procedures by the VA may have an adverse effect on our ability to sell our products to VA hospitals and may have a material adverse effect on our sales and results of operations.
- The ongoing cost‑containment efforts of GPOs and integrated delivery networks (“IDNs”) may have a material adverse effect on our results of operations.
- Significant disruptions of information technology systems or breaches of information security could adversely affect our business.
- We may expand our business through acquisitions, licenses, investments and other commercial arrangements in other companies or technologies, which contain significant risks.
- Should the FDA determine that any of our current products do not meet regulatory requirements that permit qualifying human cells, tissues and cellular and tissue‑based products to be manufactured, stored, labeled, and distributed without pre‑marketing approval, we may be required to stop manufacturing and distributing such products.
- Our business is subject to an inherently uncertain and evolving area of regulation.
- If the FDA determines that any of our current products are not 361 HCT/Ps, or that any of our future products are not 361 HCT/Ps, we will be required to seek and obtain pre‑marketing regulatory approval.
- Our business is subject to continuing regulatory compliance by the FDA and other authorities, which is costly and our failure to comply could result in negative effects on our business.
- In addition to FDA regulations, we are subject to other laws, rules, regulations, and standards regarding the use of human tissue.
- Our business involves the use of hazardous materials that could expose us to environmental and other liability.
- Federal and state laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect and use that information and subject us to liability if we are unable to fully comply with such laws.
- We face significant uncertainty in the industry due to government healthcare reform.
- Given our limited patent position in regard to our products, if we are unable to protect the confidentiality of our proprietary information and know‑how related to these products, our competitive position would be impaired and our business, financial condition, and results of operations could be adversely affected.
- If our patent position does not adequately protect our products, others could compete against us more directly, which would harm our business and have a material adverse effect on our business, financial condition, and results of operations.
- If we infringe or are alleged to infringe on intellectual property rights of third parties, it could adversely affect our business, financial condition, and results of operations.
- We may become involved in lawsuits or administrative proceedings to protect or enforce our patents or the patents of our service providers or licensors, which could be expensive and time consuming.
- The prosecution and enforcement of patents licensed to us by third parties are not within our control, and without these technologies, our products may not be successful and our business would be harmed if the patents were infringed or misappropriated.
- The trading price of the shares of our common stock is highly volatile, and purchasers of our common stock could incur substantial losses.
- We do not intend to pay cash dividends.
- Certain provisions of Maryland law and of our charter and bylaws contain provisions that could delay and discourage takeover attempts and any attempts to replace our current directors by stockholders.
- Concentration of ownership of our common stock among our existing executive officers, directors, and principal stockholders may prevent others from influencing significant corporate decisions, and provisions in our charter allowing for a stockholder vote by consent in lieu of a meeting may make it easier for stockholders holding a majority of our common stock to take action.
- We have restated our prior financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on our stock price.
- Our management has identified material weaknesses in the Company’s internal control over financial reporting which could, if not remediated, result in additional material misstatements in our consolidated financial statements. We may be unable to develop, implement and maintain appropriate controls in future periods.
- Our failure to prepare and timely file our periodic reports with the SEC limits our access to the public markets to raise debt or equity capital.
Management Discussion
- Revenue was $142.8 million for the year ended December 31, 2018, which increased $24.3 million, or 20.5%, compared with revenue of $118.5 million in 2017.
- Grafix/Stravix revenue increased $19.9 million, or 23.4%, primarily due to increased demand from improved market awareness and acceptance as we increased selling efforts in the operating room and surgical settings as well as hospital outpatient wound care centers. In October 2018, we launched our GrafixPL PRIME product which contributed to higher sales in the fourth quarter of 2018. In addition, we received a one-time settlement payment of $1.3 million from a former distributor that was accounted for on a cash basis, as collection was not reasonably assured, to settle amounts owed to us from previous years, primarily 2015 and 2016. While we are experiencing some pressure to reduce prices, the pricing of our Grafix/Stravix products did not significantly impact sales growth during the year ended December 31, 2018.
- BIO4 revenue increased $3.5 million, or 14.6%, primarily due to increased demand through our distribution arrangement with Stryker. Pricing of our BIO4 products did not significantly impact sales growth during the year ended December 31, 2018.