SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2001
Commission File No. 0-19878
OPTION CARE, INC.
(Exact name of registrant as specified in its charter)
| DELAWARE (State or other jurisdiction of incorporation or organization) |
36-3791193 (I.R.S. Employer Identification No.) |
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100 Corporate North, Suite 212 Bannockburn, Illinois (Address of principal executive offices) |
60015 (Zip Code) |
Registrant's telephone number, including area code (847) 615-1690
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 Par Value per Share
Title of Each Class
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 /x/ No / /
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. / /
The aggregate market value of voting stock held by non-affiliates of the registrant as of March 22, 2002 was approximately $270,828,437 (based on closing sale price of $16.55 per share as reported by the Nasdaq National Market and published in the Wall Street Journal.) Solely for purposes of the foregoing calculation of aggregate market value of voting stock held by non-affiliates, the registrant has assumed that all Directors and executive officers of the registrant are affiliates of the registrant. Such assumption shall not be deemed as determination by the registrant that such persons are affiliates of the registrant for any purposes.
The number of shares of the registrant's Common Stock, $.01 par value, outstanding as of March 22, 2002 was approximately 16,364,256.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant's Proxy Statement for the 2002 Annual Shareholders' Meeting are incorporated by reference into Items 10, 11, 12 and 13 in Part III of this Report.
OPTION CARE, INC.
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
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| PART I: | ||||
Item 1. |
Business |
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Item 2. |
Properties |
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Item 3. |
Legal Proceedings |
16 |
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Item 4. |
Submission of Matters to a Vote of Security Holders |
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PART II: |
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Item 5. |
Market for the Registrant's Common Stock and Related Stockholders Matters |
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Item 6. |
Selected Financial Data |
18 |
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Item 7. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
19 |
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Item 7(a). |
Quantitative and Qualitative Disclosures About Market Risk |
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Item 8. |
Financial Statements and Supplementary Data |
27 |
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Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
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PART III: |
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Item 10. |
Directors and Officers of the Registrant |
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Item 11. |
Executive Compensation |
50 |
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Item 12. |
Security Ownership of Certain Beneficial Owners and Management |
50 |
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Item 13. |
Certain Relationships and Related Transactions |
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PART IV: |
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Item 14. |
Exhibits, Financial Statement Schedule, and Reports on Form 8-K |
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The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this Annual Report on Form 10-K and other materials filed or to be filed by Option Care with the Securities and Exchange Commission (as well as information included in oral statements or other written statements made or to be made by Option Care) contain statements that are or will be forward-looking, such as statements relating to acquisitions and other business development activities, future capital expenditures and the anticipated or potential effects of future regulation and competition. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and, accordingly, such results may differ from those expressed in any forward-looking statements made by, or on behalf of, Option Care. These risks and uncertainties include, but are not limited to, uncertainties affecting businesses of Option Care and its franchisees relating to acquisitions and divestitures (including continuing obligations with respect to completed transactions), sales and renewals of franchises, government and regulatory policies (including federal, state and local efforts to reform the delivery of and payment for healthcare services), general economic conditions (including economic conditions affecting the healthcare industry in particular), the pricing and availability of goods and services, technological developments and changes in the competitive environment in which Option Care operates.
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Business
We provide pharmacy services to patients on behalf of managed care organizations and other third party payors. We contract with these payors to provide infusion therapy, specialty pharmacy and other related services to patients at home or at other alternate-site settings, such as physicians' offices. As of December 31, 2001, our pharmacy and related services are provided locally through our nationwide network of 132 owned and franchised pharmacy locations, and through our three regional specialty pharmacies, which operate under the name OptionMed. For the twelve months ended December 31, 2001, approximately 74.9% of our revenue was generated from our local pharmacy division and 25.1% from our regional specialty pharmacy division.
INDUSTRY OVERVIEW
Healthcare related expenditures constitute a large and growing segment of the US economy. According to estimates by the Centers for Medicare & Medicaid Services, national health expenditures reached $1.3 trillion in 2000 and are expected to double over the next decade. Two important trends have emerged in relation to healthcare spending:
Home Infusion Therapy
Home infusion therapy involves the intravenous administration of medications and the administration of nutrition both intravenously and through feeding tubes. Home infusion therapy is generally administered to treat infections, dehydration, cancer, pain and nutritional deficiencies. Patients are generally referred to home infusion therapy providers by physicians, hospital discharge planners or case managers. The medications are mixed and dispensed under the supervision of a registered pharmacist who is employed by the home infusion therapy provider. The therapy is generally provided in the home of the patient by a registered nurse or trained caregiver.
According to the National Home Infusion Association, the size of the home infusion therapy industry was approximately $4.5 billion in 2000. The industry is highly fragmented. We believe that several factors will contribute to the continuing growth in non-hospital based infusion therapy services, including the following:
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Specialty pharmacy services
Specialty injectable pharmaceuticals are medications which require special inventory handling and patient compliance monitoring. They typically cost over $10,000 per patient per year and require refrigeration during shipping and careful handling to prevent potency degradation. Patients receiving treatment usually require special counseling and education regarding their condition and treatment programs. The specialty pharmacy services industry has developed as a result of the proliferation of high cost specialty pharmaceuticals, which are generally injectable, for the treatment of chronic conditions such as multiple sclerosis, growth hormone disorders, hemophilia, cancer and immune deficiency disorders and other chronic conditions. There were approximately twice as many biotechnology pharmaceuticals approved by the Food and Drug Administration in 2000 than in 1995. Retail pharmacies and other traditional distributors generally are set up to carry inventories of low cost, high volume products and therefore are not equipped to handle the high cost, low volume specialty injectable pharmaceuticals that have specialized requirements. As a result, specialty injectable pharmaceuticals are generally provided by pharmacies specializing in filling, labeling and delivering specialty injectable pharmaceuticals and related specialty pharmacy services.
The national market for specialty pharmaceuticals is estimated to be approximately $22 billion according to IMS Health, Inc. data. We expect several factors to contribute to the continuing growth of the specialty pharmacy services industry, including the following:
OPTION CARE PHARMACY SOLUTION
We provide managed care organizations and other third party payors, patients, physicians and pharmaceutical manufacturers with a cost-effective solution for both home infusion therapy and specialty pharmaceutical products and services nationwide.
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monitoring to encourage patient compliance with the prescribed therapy. We also provide services to help patients receive reimbursement benefits.
BUSINESS STRATEGY
Because of our clinical experience and the geographical coverage of our 132 local pharmacies and three regional specialty pharmacies, we believe we are an attractive provider to managed care organizations, insurance companies and other third party payors and referral sources seeking a single source for infusion therapy and specialty pharmacy services. We intend to increase our revenue and profitability by implementing the following strategies:
THE LOCAL PHARMACY NETWORK
As of December 31, 2001, our local pharmacy network of 40 company-owned pharmacy locations and 92 franchised pharmacy locations provide home infusion and specialty injectable pharmaceuticals and services. Our local pharmacy locations include a number of franchised and company-owned locations that provide ancillary infusion therapy services but are not licensed pharmacies. Specialty injectable pharmaceuticals and related services sold through our local pharmacies are included in revenue from our local pharmacies. These pharmacies offer patients and physicians the following products and services:
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We provide the following home infusion therapies:
We provide specialty pharmacy services to treat the following:
We have developed specific care management programs for growth hormone deficiency, respiratory syncytial virus, hepatitis C virus and multiple sclerosis. Each of these programs provides medication, education, compliance monitoring, reimbursement assistance and other services to patients and physicians to improve clinical and cost-of-care outcomes. Through these care management programs, we are able to collect a broad range of information. This information is commonly used by the pharmaceutical manufacturers on a non-patient specific basis to assist in the long-term assessments of efficacy, side effects, compliance and other measures for their products. Each of our company-owned
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local pharmacies actively markets our care management programs to local physicians, hospitals and other health care facilities. These programs are also available through participating franchised locations.
Franchise Program
Our franchise program is designed to increase our geographical presence and to provide a national network of pharmacies to service the needs of our managed care customers without extensive capital expenditures. In marketing our franchise program, we target independent infusion pharmacies that would benefit from participating in our national and regional managed care and manufacturer contracts as well as in our marketing programs. Our franchised locations are given a license to operate a bricks and mortar Option Care branded infusion pharmacy in a defined territory to provide infusion therapy and related products and services.
We began selling franchises in 1984, and since then the program has evolved as a result of our experience. We receive a start-up fee upon execution of the franchise agreement with subsequent royalties based on a percentage of gross receipts of the franchised location. Each franchisee is required to maintain a licensed pharmacy equipped to compound medications in a sterile environment as prescribed by physicians. In the version of our program that we are currently marketing, the franchisee must use our proprietary software and obtain specified liability insurance protecting the franchise owner and us against claims arising from the operation of the franchised business. The franchised locations may participate in our managed care and manufacturer contracts. Our franchised locations may also purchase pharmaceuticals and supplies from a preferred list of vendors under contract with us. This frequently allows us and the franchisee to obtain volume discount pricing. The agreements also provide us with a right of first refusal for the potential acquisition of the franchise.
In 1992, our number of franchised locations peaked at 186. Subsequently, we reduced the number of franchised locations to increase efficiency, most often by consolidating, acquiring or terminating franchises. During that time we concentrated on growing our network of company-owned locations and, beginning in 1997, our regional specialty pharmacy business. As of December 31, 2001, we had 92 franchised pharmacy locations operating under 75 separate franchise agreements. Our existing franchise agreements begin to come up for renewal in 2004. Approximately 59% of our franchise agreements come up for renewal in the four-year period from 2006 through 2009.
The following table summarizes the termination dates of our franchise agreements, by year:
| Year ended December 31, |
Number of franchise agreements expiring |
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|---|---|---|
| 2004 | 3 | |
| 2005 | 5 | |
| 2006 | 10 | |
| 2007 | 14 | |
| 2008 | 8 | |
| 2009 | 12 | |
| 2010 | 5 | |
| 2011 | 8 | |
| 2012 | 3 | |
| 2013-2017 | 7 | |
| 75 | ||
To facilitate our regional specialty pharmacy business we have entered into participation agreements with franchisees at 52 local pharmacy locations. The participation agreements provide that we will pay a fee to the franchisee if we sell selected specialty injectible pharmaceuticals in that franchisee's territory, and also provide for a reduced royalty rate on related sales of specialty injectible
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pharmaceuticals made by the franchisee. We continue to offer participation agreements to selected franchisees. The version of our franchise agreement that we are currently marketing specifically provides for specialty pharmacy sales and related services by us in the franchised territory.
REGIONAL SPECIALTY PHARMACIES
Through our regional specialty pharmacy division, which operates under the name OptionMed, we purchase specialty injectable pharmaceuticals from manufacturers or distributors, fill prescriptions provided by physicians and label, package and deliver the pharmaceuticals to patients' homes or physicians' offices either ourselves or by using couriers such as Federal Express. Our regional specialty pharmacies currently offer over 170 different specialty injectable pharmaceuticals. Our regional specialty pharmacies are located in Miami, Florida, Ann Arbor, Michigan and Corona, California. The Miami, Florida specialty pharmacy has branch pharmacies in Jacksonville and Tampa, Florida. For the twelve months ended December 31, 2001 one managed care organization, Blue Cross and Blue Shield of Florida, accounted for approximately 72% of our regional specialty pharmacy revenue.
The following table shows our regional specialty pharmacy division's major specialty injectable pharmaceutical offerings by manufacturer, pharmaceutical and condition:
| Manufacturer |
Pharmaceutical |
Condition |
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|---|---|---|---|---|
| Amgen | Epogen Neupogen |
Dialysis Related Anemia Neutropenia |
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| AstraZeneca | Zoladex | Endometriosis | ||
| Aventis | Lovenox | DVT | ||
| Berlex | Betaseron | Multiple Sclerosis | ||
| Biogen | Avonex | Multiple Sclerosis | ||
| Bristol Myers-Squibb | Taxol | Cancer | ||
| Eli Lilly | Humatrope | Growth Hormone Deficiency | ||
| Genentech | Herceptin Nutropin |
Cancer Growth Hormone Deficiency |
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| Immunex | Enbrel Leukine Novantrone |
Rheumatoid Arthritis Neutropenia Cancer/Multiple Sclerosis |
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| MedImmune | Synagis | Respiratory Syncytial Virus | ||
| Novartis Opthalmics/QLT | Visudyne | Macular Degeneration | ||
| Ortho Biotech | Procrit | Chemotherapy Related Anemia | ||
| Schering-Plough | Intron Rebetron |
Hepatitis C Hepatitis C |
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| Serono | Serostim | AIDS Wasting | ||
| TAP | Lupron | Endometriosis | ||
| Teva | Copaxone | Multiple Sclerosis |
We purchase many of our specialty injectable pharmaceuticals through preferred distribution agreements, which often allows us to obtain volume or other discounts. As a result of our vendor arrangements, we are able to maintain a "just in time" inventory system which allows us to maintain low inventory levels. In addition, as part of these agreements with pharmaceutical manufacturers, we provide the manufacturers with non-patient specific data on patient demographics, treatment compliance and outcomes. The ability to provide this data is critical to maintain a good relationship with pharmaceutical manufacturers, to obtain distribution rights to new specialty injectable pharmaceuticals in their pipelines, and, in many instances, to obtain discounts from them. Through our services, pharmaceutical manufacturers obtain a reliable and controlled distribution channel for their products. We believe the development of our care management programs and their implementation in
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our local pharmacy network, along with our ability to provide specific case management services when needed, will be a significant factor in allowing us to become a preferred specialty pharmacy services provider for biotech and other pharmaceutical companies offering new specialty injectable pharmaceuticals.
CUSTOMERS
We derive most of our revenue from third party payors, such as managed care organizations, insurance companies, self-insured employers and Medicare and Medicaid programs. Currently, we have over 500 contracts with over 300 managed care organizations covering over 75 million lives. Of these, twelve contracts relate to our regional specialty pharmacy business. Where permissible, we bill patients for any amounts not reimbursed by third party payors. For the most part, our local pharmacy segment revenue consists of reimbursement for both the cost of the pharmaceuticals sold and the cost of services provided. Typically, pharmaceuticals are reimbursed on a percentage discount from the published average wholesale price of each drug, while nursing services and ancillary medical supplies are reimbursed on a per diem basis. This differs from our regional specialty pharmacy segment, in which revenue is based only on a percentage discount from average wholesale prices. Since specialty pharmaceuticals are typically pre-packaged drugs that are self-injected by the patient, minimal service is provided. Therefore, no per diem revenue is generated.
Our principal managed care contract is with Blue Cross and Blue Shield of Florida, Inc. which contracts with us through our regional pharmacy located in Miami, Florida. We entered into our initial contract with this customer in June 1997. In April 2001, we entered into an interim amendment to the contract pending final negotiation of a new contract which provided for reduced pricing and an expansion of the number of Blue Cross and Blue Shield of Florida, Inc. patients to which we may provide pharmaceuticals. In September 2001, we executed the new contract with Blue Cross and Blue Shield of Florida, Inc. which replaced our prior agreement with them regarding specialty injectable pharmaceuticals. This contract is for an initial term of one year, is terminable by either party upon 90 days notice and, unless terminated, renews annually each September for an additional one-year term. The new contract further expands the number of Blue Cross and Blue Shield of Florida, Inc. patients to which we may provide pharmaceuticals. We have begun to implement expanded services under this contract, and expect to continue this expansion over the next 12 to 18 months. There are no minimum purchase requirements in this contract. Our revenue from Blue Cross and Blue Shield of Florida, Inc. has increased from approximately $21.5 million in 1998 to $45.7 million in 2001. In 2001, 2000 and 1999, approximately 22%, 27% and 25% of our total pharmacy revenue, which is our total revenue other than revenue from royalties, product sales and other revenue, and approximately 72%, 74% and 77% of our regional specialty pharmacy revenue was related to this contract. As of December 31, 2001 and 2000, approximately 11% of Option Care's total accounts receivable was from Blue Cross and Blue Shield of Florida, Inc.
For the twelve months ended December 31, 2001, 2000 and 1999, respectively, approximately 15%, 16% and 18% of our total pharmacy revenue came from governmental programs such as Medicare and Medicaid. The accounts receivable related to these programs represented approximately 17% and 19% of our total accounts receivable as of December 31, 2001 and 2000, respectively.
ACQUISITION PROGRAM
The acquisition of independent infusion pharmacies and selected franchised locations is an important part of our growth strategy. Acquisition candidates are evaluated based on the pharmacy's location, profitability, consolidation opportunities, existing relationships in the marketplace and prospects for growth. The success of our acquisition program is significantly dependent upon our successful integration of the acquired pharmacy into our system. New office integration is a defined
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process which is accomplished by our integration team, made up of representatives from our clinical, human resources, accounting, purchasing, management information and reimbursement departments.
PROPRIETARY DATA MANAGEMENT SYSTEM
Our wholly owned subsidiary, Management by Information, Inc. has developed a proprietary software system called "Management by Information Homecare 5.0," which is designed to manage the intake, dispensing, clinical, billing and collection processes for home infusion and specialty pharmacies. The product also contains a component for managing the clinical, billing, and inventory tracking functions for respiratory therapy/durable medical equipment (RT/DME) businesses. We license and service our software system to non-affiliated home infusion pharmacy and durable medical equipment companies, and to several of our franchised local pharmacies. We also use the Management by Information system internally to manage the operations of our regional specialty pharmacies and company-owned local pharmacies. We believe that this system gives us an advantage over our competitors in the specialty pharmacy market by providing us with the ability to gather and organize data for many different uses. For example, a pharmaceutical manufacturer may request certain data in a format that is customized to meet that particular manufacturer's needs. All company-owned local pharmacies, except for a few recently acquired pharmacies, use the Management by Information system in the management of their operations.
Management by Information, Inc. is in the final stages of developing the next generation of its software product, which will eventually replace the existing MBI product. The new system is anticipated to be ready for release in the second quarter of 2002. It will be a web-enabled, browser-based system versus the existing DOS-based system. We plan to have the new MBI software installed and operating in all of our company-owned local pharmacies and regional specialty pharmacies by the end of 2003.
SALES AND MARKETING
We conduct our sales and marketing efforts through two sales segments. The first segment is comprised of our Senior Vice President of Sales and our eight Regional Sales Directors. This group focuses on developing new contracts with national and regional managed care organizations and other third party payors for both our local pharmacy network and our regional specialty pharmacy business. These Regional Sales Directors manage the second segment of our sales force, which is comprised of more than 50 Account Managers who focus on developing new infusion therapy and specialty pharmacy business on local and regional levels. These Account Managers are located in our company-owned local pharmacies throughout the United States. Positioning sales personnel on a local level allows us to focus on referral sources such as physicians, hospital discharge planners and case managers.
Substantially all of our new patients are referred by physicians, medical groups, hospital discharge planners, case managers employed by Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs) or other managed care organizations, insurance companies and home care agencies. Our sales force is responsible for establishing and maintaining these referral sources.
Our two-tier system of marketing allows us to pass leads from our national managed care contacts to our network of locally-placed sales personnel. Additionally, the existence of our contracts with national managed care organizations provide our local sales personnel with more flexibility and leverage for sales in local markets. This cross-utility enables us to market our services to numerous sources of patient referrals, including physicians, hospital discharge planners, hospital personnel, HMOs, PPOs or other managed care organizations, and insurance companies. Local marketing focuses on our infusion therapy business and our care management programs, with an emphasis on certain key therapies.
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COMPETITION
Our local pharmacies primarily compete in the large and highly fragmented home infusion market for contracts with managed care organizations and other third party payors and referrals from physicians, case managers and hospital discharge planners. Competition in the home infusion market is based on quality of care, cost of service and reputation. Some of our current and potential future competitors include integrated home healthcare providers such as Apria Healthcare Group Inc. and Coram Healthcare Corporation, and local providers of alternate site healthcare services such as hospitals, local home health agencies and other local providers. Some of these competitors have, and our potential future competitors may have, greater financial, operational, sales and marketing resources than us. However, we believe that our reputation for providing quality services, the strength of our growing national presence and our ability to effectively market our services at a national, regional and local level places us in a strong position against current and potential future competitors.
Our regional specialty pharmacies compete in the large and highly fragmented specialty pharmacy services market. We face competition in obtaining contracts with managed care organizations and other third party payors and for distribution contracts with pharmaceutical manufacturers. Competition in the specialty pharmacy market is based on price, reliability of service and reputation. Some of our current and potential future competitors include specialty pharmacy providers such as Accredo Health Inc., Priority Healthcare Corporation, Caremark Therapeutic Services and others, specialized retail pharmacies such as ProCare, a division of CVS Corporation, pharmacy benefit management companies and retail pharmacies. Some of these competitors have, and our potential future competitors may have, greater financial, operational, sales and marketing resources than us.
GOVERNMENTAL REGULATION
The healthcare industry is subject to extensive regulation by a number of governmental entities at the federal, state and local level. The industry is also subject to frequent regulatory change. Laws and regulations in the healthcare industry are extremely complex and, in many instances, the industry does not have the benefit of significant regulatory or judicial interpretation. Moreover, our business is impacted not only by those laws and regulations that are directly applicable to us but also by certain laws and regulations that are applicable to our managed care and other clients. If we fail to comply with the laws and regulations directly applicable to our business, we could suffer civil and/or criminal penalties and we could be excluded from participating in Medicare, Medicaid and other federal and state healthcare programs.
If our franchisees fail to comply with the laws and regulations applicable to their businesses, they could suffer civil and/or criminal penalties and/or be excluded from participating in Medicare, Medicaid and other federal and state healthcare programs, which could have an adverse impact on our business.
The healthcare industry is undergoing significant change as third party payors, such as Medicare and Medicaid, health maintenance organizations and other health insurance carriers increase efforts to control the cost, utilization and delivery of healthcare services. Reductions in reimbursement by Medicare and Medicaid and other third party payors may be implemented from time to time. These cost control efforts may result in a decline in the prices for which we are able to sell our products and services, which would have a material adverse effect on our gross profit margins and overall profitability.
Professional Licensure. Nurses, pharmacists and other healthcare professionals employed by us are required to be individually licensed or certified under applicable state law. We take steps to ensure that our employees possess all necessary licenses and certifications, and we believe that our employees comply in all material respects with applicable licensure laws.
Each of our franchisees is responsible for ensuring the licensing or certification of its employees in accordance with applicable law, performing any criminal or other background checks required by state law, and ensuring that all employees perform only those tasks which fall within their authorized scope
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of practice. Each franchisee is responsible for any failure or non-compliance with respect to these licensure and scope of practice issues.
Pharmacy Licensing and Registration. State laws require that each of our pharmacy locations be licensed as an in-state pharmacy to dispense pharmaceuticals in that state. Certain states also require that certain of our pharmacy locations be licensed as an out-of-state pharmacy if we deliver prescription pharmaceuticals into those states from locations outside of the state. We believe that we substantially comply with all state licensing laws applicable to our business. If we are unable to maintain our licenses or if states place burdensome restrictions or limitations on non-resident pharmacies, our ability to operate in some states would be limited, which could adversely impact our business and results of operations.
Laws enforced by the Drug Enforcement Administration, as well as some similar state agencies, require our pharmacy locations to individually register in order to handle controlled substances, including prescription pharmaceuticals. A separate registration is required at each principal place of business where the applicant dispenses controlled substances. Federal and state laws also require that we follow specific labeling, reporting and record-keeping requirements for controlled substances. We maintain federal and state controlled substance registrations for each of our facilities that require such registration and follow procedures intended to comply with all such record-keeping requirements.
Many states in which we are operating also require home infusion companies to be licensed as home health agencies. We believe we are in compliance with these laws as applicable.
Food, Drug and Cosmetic Act. Provisions of this federal law govern the handling and distribution of pharmaceutical products. This law exempts many pharmaceuticals and medical devices from federal labeling and packaging requirements as long as they are not adulterated or misbranded and are dispensed in accordance with and pursuant to a valid prescription. To the extent that this law applies to us, we believe that we comply with the documentation, record-keeping and storage requirements.
Fraud and Abuse LawsAnti-Kickback Statute. The federal Anti-Kickback statute prohibits individuals and entities from knowingly and willfully paying, offering, receiving, or soliciting money or anything else of value in order to induce the referral of patients or to induce a person to purchase, lease, order, arrange for, or recommend services or goods covered by Medicare, Medicaid, or other government healthcare programs. The Anti-Kickback statute is extremely broad and potentially covers many standard business arrangements. Violations can lead to significant criminal and civil penalties, including fines of up to $25,000 per violation, civil monetary penalties of up to $50,000 per violation, imprisonment, and/or exclusion from participation in Medicare, Medicaid, and other government healthcare programs. The Office of the Inspector General of the United States Department of Health and Human Services has published regulations that identify a limited number of specific business practices that fall within safe harbors guaranteed not to violate the Anti-Kickback statute. We attempt to safe harbor our business relationships. But while not all of our business relationships meet all of the elements of the published safe harbors, conformity with the safe harbors is not mandatory and failure to meet all of the requirements of an applicable safe harbor does not make conduct illegal. The Office of Inspector General is authorized to issue advisory opinions regarding the interpretation and applicability of the federal Anti-Kickback law, including whether an activity constitutes grounds for the imposition of civil or criminal sanctions. We have not, however, sought such an opinion.
A number of states have in place statutes and regulations that prohibit the same general types of conduct as those prohibited by the federal laws described above. Some states' anti-fraud and anti-kickback laws apply only to goods and services covered by Medicaid. Other states' anti-fraud and anti-kickback laws apply to all healthcare goods and services, regardless of whether the source of payment is governmental or private.
Fraud and Abuse LawsFalse Claims Act. We are subject to state and federal laws that govern the submission of claims for reimbursement. These laws generally prohibit an individual or entity from
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knowingly and willfully presenting a claim or causing a claim to be presented for payment from Medicare, Medicaid or other third party payors that is false or fraudulent. The standard for "knowing and willful" often includes conduct that amounts to a reckless disregard for whether accurate information is presented by claims processors. Penalties under these statutes include substantial civil and criminal fines, exclusion from the Medicare program and imprisonment. One of the most prominent of these laws is the federal False Claims Act, which may be enforced by the federal government directly or by a private plaintiff on the government's behalf. Under the False Claims Act, both the government and the private plaintiff, if successful, are permitted to recover substantial monetary penalties, as well as an amount equal to three times actual damages. A number of states, including states in which we operate, have adopted their own false claims provisions as well as their own qui tam provisions whereby a private party may file a civil lawsuit in state court. We believe that we have procedures in place to ensure the accurate completion of claims forms and requests for payment by facilities owned by us.
In recent years, federal and state government agencies have increased the level of enforcement resources and activities targeted at the healthcare industry. In addition, federal law allows individuals to bring lawsuits on behalf of the government alleging false or fraudulent Medicare or Medicaid claims and certain other violations of federal law. The use of these private enforcement actions against healthcare providers has increased dramatically in the recent past, in part because the individual filing the initial complaint is entitled to share in a portion of any settlement or judgment.
Limitations on Physician Self-Referral Law (Stark Law). The federal Stark Law generally prohibits a physician from making referrals for certain health services, reimbursable by Medicare or Medicaid, to entities in which the physician or a family member has an ownership or investment interest or a compensation relationship. Like the Anti-Kickback Statute, the Stark Law exempts certain business relationships structured in accordance with one of the exceptions set forth in the statute. On January 4, 2001, the Center for Medicare and Medicaid Services issued Phase I of the final Stark Law regulations in the form of a final rule. The Center for Medicare and Medicaid Services previously issued proposed regulations regarding the Stark Law on January 9, 1998 covering the same general subject matter as the Phase I guidance and the to-be-provided Phase II guidance. The Stark Law is currently in effect and most of the provisions of the Phase I regulations became effective on January 4, 2002. However, liberalized rules regarding physician financial relationships with home health services became effective February 5, 2001.
The Phase I regulations address the provisions in paragraphs (a), (b), and (h) of Section 1877 of the Social Security Act and applies to services covered by Medicare, Medicaid, and other government healthcare programs. Those subsections cover: the Stark Law's prohibition on referrals for designated health services by physicians to entities with which they have a financial relationship unless an exception applies; the exceptions that apply to ownership and/or compensation arrangements; and definitions of Stark Law terms, including definitions of "group practice" and each of the identified designated health services. Designated Health Services include outpatient pharmaceuticals, parenteral and enteral nutrition products; home health services; durable medical equipment; physical and occupational therapy services; and inpatient and outpatient hospital services.
Phase II will address the ownership/investment and compensation exceptions in paragraphs (c), (d) and (e) of Section 1877 and the reporting requirements and sanctions under paragraphs (f) and (g), respectively, and will further address the exception for services furnished in an ambulatory surgical center in an end-stage renal dialysis facility or by a hospice organization. Phase II will also address Section 1903(s) of the Act that which extends aspects of the referral prohibition to the Medicaid Program; comments received in response to Phase I; certain proposals for new exceptions; and reporting requirements.
The Center for Medicare and Medicaid Services promises to release Phase II in the near future. However, because Phase I solicited comments for Phase II that were due by April 4, 2001, it is unlikely that Phase II will be released any earlier than the summer of 2002. Based on experience with previous
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Stark Law comments that were published more than two years after the close of the comment period, it may be much longer before Phase II is released and the impact of the new regulations will have to then be assessed.
Health Insurance Portability and Accountability Act of 1996 (HIPAA). Subtitle F of the Health Insurance Portability and Accountability Act of 1996 was enacted to improve the efficiency and effectiveness of the healthcare system through the establishment of standards and requirements for the electronic transmission of certain health information. To achieve that end, the act requires the Secretary of the United States Department of Health and Human Services (DHHS) to promulgate a set of interlocking regulations establishing standards and protections for health information systems, including standards for the following:
Final rules setting forth standards for electronic transactions and code sets were published on August 17, 2000 and for the privacy of individually identifiable health information on December 28, 2000, both of which apply to health plans, healthcare clearinghouses and healthcare providers who transmit any health information in electronic form in connection with certain administrative and billing transactions. On March 27, 2002, DHHS published proposed modifications to the final privacy rule with a thirty day comment period. The primary goal of the proposed modifications is to ensure that the privacy regulations do not impede access to care. Proposed rules that include standards for unique health identifiers for employers and healthcare providers, as well as standards related to the security of individual health information and the use of electronic signatures have been published.
Compliance with the standards for electronic transactions and code sets is required by October 2002. However, pursuant to the Administrative Simplification and Compliance Act, a provider may file a compliance plan with the Centers for Medicare and Medicaid Services to extend the provider's compliance deadline from October 2002 to October 2003. Compliance with the privacy regulations is required by April 2003. Compliance with the proposed rules for health identifiers and security standards is not expected to be required before 2003.
We are currently evaluating the effect of the proposed and final rules published to date and have developed a task force to address the standards set forth in these rules and their effect on our business. Given the complexity of the regulations and the fact that not all of the standards have been issued in final form, we cannot estimate at this time the cost of compliance.
HIPAA also has created new healthcare related crimes, and granted authority to the Secretary of the DHHS to impose certain civil penalties. Particularly, the Secretary may now exclude from Medicare any individual with a direct or indirect ownership interest in an entity convicted of health care fraud or excluded from the program. HIPAA encourages the reporting of health care fraud by allowing reporting individuals to share in any recovery made by the government. HIPAA also requires new programs to control fraud and abuse, and new investigations, audits and inspections.
New crimes under HIPAA include:
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These provisions of HIPAA criminalized situations that previously were handled exclusively civilly through repayments of overpayments, offsets and fines. We believe that our business arrangements and practices comply with HIPAA. However, a violation could subject us to penalties, fines or possible exclusion from Medicare or Medicaid. Such sanctions could reduce our revenue or profits.
Balanced Budget Act. Each state operates a Medicaid program funded in part by the Federal government. The states may customize their programs within federal limitations. Each state program has its own payment formula and recipient eligibility criteria. In recent years, changes in Medicare and Medicaid programs have resulted in limitations on, and reduced levels of, payment and reimbursement for a substantial portion of health care goods and services. For example, the federal Balanced Budget Act of 1997, even after the restoration of some funding in 1999 and 2000, will continue to cause significant reductions in spending levels for the Medicare and Medicaid programs. In spring of 2000, some state Medicaid agencies reduced their reimbursement rates to correspond to the new average wholesale prices published by First Data Bank.
Franchise Regulation. We are subject to regulations adopted by the Federal Trade Commission (FTC), and to certain state laws that regulate the offer and sale of franchises. The FTC's Trade Regulation Rule on Franchising and certain state laws require that we furnish prospective franchise owners with a Uniform Franchise Offering Circular (UFOC) containing information prescribed by the Rule and applicable state laws and regulations. There are certain states that also regulate the offer and sale of franchises and, in almost all cases, require registration of the UFOC with state authorities.
We are also subject to a number of state laws that regulate some substantive aspects of the franchisor-franchisee relationship. These laws may limit a franchisor's ability to:
These laws also may limit the duration and scope of non-competition provisions. To date, these laws have not precluded us from seeking franchisees in any given area and have not had a material adverse effect on our operations.
Although bills intended to regulate certain aspects of franchise relationships have been introduced into Congress on several occasions during the past decade, none have been enacted. We are not aware of any pending franchise legislation that in our view is likely to significantly affect our operations. We believe that our operations comply substantially with the Rule and applicable state franchise laws.
SERVICE MARKS
We have registered with the federal government OPTION CARE®, OptionMed and MBI®, among others, as service marks. We believe that Option Care is becoming increasingly recognized by many referral sources as representing a reliable, cost-effective source of pharmacy services. We believe that the use of these service marks does not violate or otherwise infringe upon the rights of others.
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EMPLOYEES
As of December 31, 2001, we employed 1,074 persons on a full-time basis and 588 persons on a part-time basis. Of our full-time employees, 89 were corporate management and administrative personnel and the remaining 985 were employees of company-owned locations, primarily in clinical, management and administrative positions.
We consider employee relations to be good. None of our employees is covered by a collective bargaining agreement.
Our executive offices, located at 100 Corporate North, Suite 212, Bannockburn, Illinois, 60015, consist of approximately 18,845 square feet of leased space. Upon expiration of our existing lease in May 2002, we are planning to relocate our executive offices to a new premises, consisting of 28,786 square feet of leased space located at 485 Half Day Road, Suite 300, Buffalo Grove, Illinois, 60089, pursuant to a ten-year, three month lease. Base monthly rent payments will range from approximately $35,000 per month for the first year of the lease to approximately $52,000 per month for the last year. Real estate taxes and maintenance costs will be our responsibility and are over and above the base rent. We have the option to accelerate the expiration date of this lease by three years upon payment of a fee.
In addition to our executive offices, at December 31, 2001, we had facilities in approximately 46 cities throughout the United States. All of these facilities are leased, with remaining terms ranging from one month to eight years. These facilities consist of approximately 279,000 square feet in total. The offices are in good condition, well maintained, and are adequate to fulfill our operational needs for the foreseeable future. We believe that if necessary, we could replace any of our facility leases without significant additional cost or adverse affect on our business.
In early 2002, we signed a lease for a new facility in Miami, Florida to replace the existing facility in that city. We also signed a lease for a new facility in Dallas, Texas in order to consolidate four Dallas area offices into one facility for improved efficiency. The new Miami and Dallas leases, along with our facility lease in Bellingham, Washington, are our most significant, aside from our executive office lease described above. The new Miami, Florida lease is for a term of ten years, with monthly base rent ranging from approximately $15,000 per month in the first year of the lease to approximately $19,000 per month in the tenth year. The new Dallas, Texas lease is for a five-year term, with monthly payments, including shared operating expenses, equaling approximately $17,000 per month throughout the lease term. Our lease in Bellingham, Washington became effective December 1, 2001, is for a term of eight years, and requires base rent payments ranging from $13,000 per month in the first year of the lease to approximately $17,000 per month in the last year.
From time to time, we are named as a party to legal claims and proceedings in the ordinary course of business. Additionally, from time to time, governmental and regulatory agencies may initiate investigations or proceedings against us in the ordinary course of business, or which have general application to the businesses we operate. We are not aware of any claims, investigations or proceedings against us or any of our franchisees that we believe are likely to have a material financial impact on us.
We had previously reported that on October 10, 2001, a lawsuit captioned I.V. Associates, Inc. v. Option Care, Inc., Civil Action No.01-4726, was filed in the U.S. District Court for the District of New Jersey and was served on Option Care, Inc. on October 24, 2001. This proceeding has been resolved and the lawsuit was dismissed with prejudice on March 6, 2002.
We currently maintain insurance for general and professional liability claims in an aggregate amount of $10 million. We also require each franchisee to maintain general liability and professional
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liability insurance covering both the franchise and us, at coverage levels that we believe to be sufficient. These policies provide coverage on a claims-made or occurrence basis and have certain exclusions from coverage. These insurance policies generally must be renewed annually. There can be no assurance that insurance coverage will be adequate to cover liability claims that may be asserted against us or that adequate insurance will be available in the future at acceptable cost, if at all. To the extent that liability insurance is not adequate to cover liability claims against us, we will be responsible for the excess.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
There were no matters submitted to a vote of security holders through the solicitation of proxies, or by any other means during the fourth quarter of the fiscal year ended December 31, 2001.
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Option Care is traded on the Nasdaq National Market under the symbol "OPTN". The following table shows the high and low sale prices for our Common Stock for the periods indicated.
| Calendar Quarter |
High |
Low |
||||
|---|---|---|---|---|---|---|
| 2001 | ||||||
| Fourth Quarter | $ | 19.74 | $ | 13.50 | ||
| Third Quarter | $ | 22.15 | $ | 10.95 | ||
| Second Quarter | $ | 17.94 | $ | 8.44 | ||
| First Quarter | $ | 10.00 | $ | 4.88 | ||
| 2000 | ||||||
| Fourth Quarter | $ | 7.75 | $ | 5.50 | ||
| Third Quarter | $ | 7.38 | $ | 4.94 | ||
| Second Quarter | $ | 8.06 | $ | 4.50 | ||
| First Quarter | $ | 8.75 | $ | 2.75 | ||
On March 22, 2002, the closing price of our common stock on the Nasdaq National Market was $16.55. As of March 22, 2002, there were approximately 228 holders of record of our common stock.
We have not declared or paid cash dividends on our common stock in the past and do not intend to pay dividends on our common stock in the foreseeable future.
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Item 6. SELECTED CONSOLIDATED FINANCIAL DATA
In the table below, we provide you with summary historical financial data of Option Care. We have prepared this information using the consolidated financial statements of Option Care for the five years ended December 31, 2001. The financial statements for the four years ended December 31, 2001 have been audited by Ernst & Young LLP, independent auditors. The financial statements for the year ended December 31, 1997 have been audited by other independent auditors. The selected consolidated financial data reflects our acquisitions, all of which were accounted for using the purchase method of accounting. This summary should be read in conjunction with our Consolidated Financial Statements and Notes thereto, contained elsewhere in this Annual Report on Form 10-K.
Consolidated Statement of Operations Data:
| |
Years Ended December 31, |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
2001 |
2000 |
1999 |
1998 |
1997 |
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| |
(dollars in thousands, except per share data) |
||||||||||||||||
| Revenue: | |||||||||||||||||
| Local pharmacy: | |||||||||||||||||
| Infusion and specialty pharmacy | $ | 151,233 | $ | 90,523 | $ | 78,686 | $ | 74,949 | $ | 71,992 | |||||||
| Royalties | 8,598 | 8,795 | 8,702 | 8,700 | 9,880 | ||||||||||||
| Product sales and other | 2,726 | 2,913 | 3,134 | 10,121 | 11,451 | ||||||||||||
| Total local pharmacy | 162,557 | 102,231 | 90,522 | 93,770 | 93,323 | ||||||||||||
| Regional specialty pharmacy | 54,576 | 39,043 | 29,927 | 21,170 | 7,170 | ||||||||||||
| Total revenue | 217,133 | 141,274 | 120,449 | 114,940 | 100,493 | ||||||||||||
| Cost of revenue: | |||||||||||||||||
| Local pharmacy | 95,917 | 54,076 | 45,464 | 50,221 | 51,112 | ||||||||||||
| Regional specialty pharmacy | 48,739 | 33,709 | 25,290 | 18,888 | 6,397 | ||||||||||||
| Total cost of revenue | 144,656 | 87,785 | 70,754 | 69,109 | 57,509 | ||||||||||||
| Gross profit | 72,477 | 53,489 | 49,695 | 45,831 | 42,984 | ||||||||||||
| Operating expenses | 54,907 | 40,415 | 40,411 | 43,293 | 44,661 | ||||||||||||
| Operating income (loss) | 17,570 | 13,074 | 9,284 | 2,538 | (1,677 | ) | |||||||||||
| Net income (loss) | $ | 9,957 | $ | 7,455 | $ | 4,627 | $ | (691 | ) | $ | (2,097 | ) | |||||
| Net income (loss) per common sharediluted | $ | 0.73 | $ | 0.60 | $ | 0.39 | $ | (0.06 | ) | $ | (0.19 | ) | |||||
| Weighted average number of shares and equivalents outstandingdiluted | 13,678 | 12,488 | 11,926 | 11,071 | 10,879 | ||||||||||||
Consolidated balance sheet data:
| |
As of December 31, |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
2001 |
2000 |
1999 |
1998 |
1997 |
||||||||||
| |
(in thousands) |
||||||||||||||
| Working capital | $ | 56,357 | $ | 20,994 | $ | 11,676 | $ | 19,796 | $ | 25,901 | |||||
| Total assets | 125,262 | 66,825 | 57,634 | 59,392 | 68,639 | ||||||||||
| Current portion of long-term debt | 265 | 833 | 142 | 262 | 314 | ||||||||||
| Other current liabilities | 21,077 | 13,546 | 18,625 | 12,790 | 15,688 | ||||||||||
| Long-term debt, less current portion | 353 | 11,951 | 8,448 | 22,096 | 28,801 | ||||||||||
| Stockholders' equity | 100,766 | 38,668 | |||||||||||||