UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
| x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended January 1, 2005
OR
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-23249
PRIORITY HEALTHCARE CORPORATION
(Exact name of registrant as specified in its charter)
| Indiana | 35-1927379 | |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
| 250 Technology Park Lake Mary, Florida |
32746 | |
| (Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (407) 804-6700
Securities registered pursuant to Section 12(b) of the Act:
NONE
Securities registered pursuant to Section 12(g) of the Act:
CLASS A COMMON STOCK, $.01 PAR VALUE
CLASS B COMMON STOCK, $.01 PAR VALUE
(Title of 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 Registrants 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. ¨
Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes x No ¨
$817,615,317
Aggregate market value of the voting stock held by nonaffiliates of the Registrant based on the last sale price for such stock on July 3, 2004 (assuming solely for the purposes of this calculation that all Directors and executive officers of the Registrant are affiliates).
6,584,313
Number of shares of Class A Common Stock, $.01 par value, outstanding at March 1, 2005.
37,230,206
Number of shares of Class B Common Stock, $.01 par value, outstanding at March 1, 2005.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the following document have been incorporated by reference into this Annual Report on Form 10-K:
| IDENTITY OF DOCUMENT |
PART OF FORM 10-K INTO WHICH DOCUMENT IS INCORPORATED | |
| Definitive Proxy Statement for the Annual Meeting of Shareholders to be held May 16, 2005 |
PART III |
PRIORITY HEALTHCARE CORPORATION
Lake Mary, Florida
Annual Report to Securities and Exchange Commission
January 1, 2005
PART I
Forward-Looking Statements
Certain statements included in this annual report, which are not historical facts, are forward-looking statements. Such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent our expectations or beliefs and involve certain risks and uncertainties that are beyond our control. Factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements include, but are not limited to, the effect of our internal growth and future acquisitions, changes in our supplier relationships, changes in third party reimbursement rates, changes in our customer mix and the financial stability of major customers, competitive pressures, our ability to successfully integrate acquired businesses, including the achievement of cost savings and revenue enhancements, changes in government regulations or the interpretation of these regulations and changes in interest rates. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date herein.
ITEM 1. BUSINESS.
Background
Priority Healthcare Corporation (Priority, the Company, we or us) was formed by Bindley Western Industries, Inc. (BWI) on June 23, 1994 as an Indiana corporation to focus on the distribution of products and provision of services to the specialty distribution segment of the healthcare industry. The Company conducts the business activities of specialty pharmacy and distribution healthcare companies acquired by BWI or the Company since February 1993. The principal executive offices of the Company are located at 250 Technology Park, Lake Mary, Florida 32746 and its telephone number at that address is (407) 804-6700. On October 29, 1997, the Company consummated an initial public offering of its Class B Common Stock (the IPO). On December 31, 1998, BWI distributed to its common shareholders all of the 30,642,858 shares of the Companys Class A Common Stock then owned by BWI in a spin-off transaction and BWI no longer has any ownership interest in the Company.
The Company makes available free of charge on or through its Internet website at www.priorityhealthcare.com its annual reports on Form 10-K, its quarterly reports on Form 10-Q, its current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after it electronically files such material with, or furnishes it to, the Securities and Exchange Commission.
General
Priority is a premier healthcare services company providing innovative, high quality and cost-effective solutions that enhance quality of life. As a national specialty pharmacy and distributor, Priority provides biopharmaceuticals, complex therapies, related disease treatment programs and a portfolio of other service offerings for patients, payors, physicians and pharmaceutical manufacturers. The growing number of specialty areas serviced by Priority include oncology, gastroenterology, reproductive endocrinology, neurology, hematology, pulmonology, ophthalmology, rhuematology, endocrinology, infectious disease and nephrology, as well as ambulatory surgery centers. The Company sells over 5,000 Stock Keeping Units (SKUs) of specialty pharmaceuticals and medical supplies to outpatient renal care centers and office-based physicians in oncology and other physician specialty markets. Priority offers value-added services to meet the specific needs of these markets by shipping refrigerated pharmaceuticals overnight in special packaging to maintain appropriate temperatures, offering automated order entry services and offering customized distribution for group accounts. From distribution centers in Sparks, Nevada and Grove City, Ohio, Priority services over 7,000 customers in all 50 states, including office-based oncologists, renal dialysis clinics, ambulatory surgery centers and primary care physicians.
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The Company also fills individual patient prescriptions, primarily for self-administered biopharmaceuticals. These patient-specific prescriptions are filled at 32 licensed pharmacies in 17 states and are primarily shipped directly to the patient overnight in specialized packages. Additionally, Priority offers some home-based specialty infusion therapy services. Over 98% of the Companys sales relates to the sale of biopharmaceuticals. Priority also provides disease treatment programs for hepatitis C, cancer, infertility, hemophilia, human growth hormone deficiency, rheumatoid arthritis, Crohns disease, infertility, pulmonary hypertension, pain management, multiple sclerosis, sinusitis, age-related macular degeneration, idiopathic pulmonary fibrosis, immune deficiencies, psoriasis, cystic fibrosis and others. These programs are branded as disease specific Caring Paths.
The Company is also a provider of reimbursement solutions and product support to pharmaceutical manufacturers, biotechnology companies and medical device companies.
Prioritys net sales have increased from $107 million in 1994 to $1.74 billion in 2004. In the same period, operating income has increased from $2.3 million in 1994 to $76.8 million in 2004. The Companys objective is to continue to grow rapidly and enhance its market position as a leading healthcare company by capitalizing on its business strengths and pursuing the following strategy: (i) continue to focus on further penetrating the core specialty distribution and pharmacy market; (ii) develop new manufacturer relationships that provide access to new products and services; (iii) continue to develop group purchasing organization and payor networks; (iv) enter new specialty markets; and (v) pursue acquisitions to complement existing product offerings and further penetrate markets.
Acquisitions
Over the last five years, the Company has completed the following acquisitions: On January 20, 2001, the Company acquired substantially all of the assets of three related companies doing business as Freedom Drug (Freedom Drug), the nations leading infertility specialty pharmacy, located in Lynnfield, Massachusetts and Stratham, New Hampshire. Effective March 31, 2001, the Company acquired substantially all of the assets of Physicians Formulary International, Inc. (Physicians Formulary), a distributor in the outpatient surgery center market located in Phoenix, Arizona. Effective October 26, 2001, the Company acquired substantially all of the assets of Chesapeake Infusion LLC, doing business as InfuRx (InfuRx), a specialty pharmacy located in New Castle, Delaware and Memphis, Tennessee. On March 11, 2002, the Company acquired substantially all of the assets of Hemophilia of the Sunshine State (HOSS), the leading provider of hemophilia products and services in the State of Florida, located in Oldsmar, Florida. Effective September 11, 2003, the Company acquired substantially all of the assets of SinusPharmacy Corporation (Sinus), the leading provider of intranasal nebulized therapies for the treatment of chronic sinusitis, located in Carpinteria, California. On April 2, 2004, the Company acquired certain assets of Partners In Care Pharmacy, LLC (Partners In Care), an infertility specialty pharmacy located in Mt. Prospect, Illinois. On June 14, 2004, the Company acquired all of the outstanding common shares of HealthBridge Reimbursement and Product Support, Inc. (HealthBridge), a service company specializing in drug launch and reimbursement support for the biotech and pharmaceutical industry, located in Braintree, Massachusetts. On July 6, 2004, the Company acquired all of the outstanding common shares of Integrity Healthcare Services, Inc. (Integrity), a specialty infusion pharmacy with 23 branches in 16 states located throughout the Midwest and Southeast states.
Industry and Market Overview
Priority sells the majority of its products and services into large and growing specialty marketsoncology, gastroenterology, rheumatology, endocrinology, pulmonology, neurology, infertility, chronic sinusitis, ophthalmology and chronic renal dialysis. The Company also operates in certain areas of the vaccine, oral surgery and other chronic disease markets. The common characteristics of these markets are that most products are administered in an alternate site setting by physicians or the patients themselves and require specialized shipping and support services.
Industry Overview. The specialty distribution market is fragmented with several public and many small private companies focusing on different product or customer niches. Few companies offer a wide range of pharmaceuticals and related supplies targeted to multiple customer groups, specifically office-based physicians and
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patients self-administering (injecting, infusing, or receiving therapy) at home. Historically, cancer therapy, renal dialysis and most other treatments for chronic and life-threatening medical conditions were administered almost exclusively in a hospital inpatient setting. In recent years, the frequency with which these treatments have been administered outside the hospital has increased dramatically in response to cost containment efforts and the introduction of new biopharmaceutical products, such as PEG-Intron®, Rebetol®, Pegasys®, Copegus®, Remodulin®, Actimmune®, Epogen®, Xolair®, Apokyn and many others.
The service needs of office-based physicians and patients self-administering at home differ markedly from those of the hospital market, creating logistical challenges and increasing administrative costs for those offices. Office-based physicians and clinics generally order relatively small quantities of drugs at irregular intervals and do not have inventory management systems or sufficient pharmacy staffing. Challenges facing these caregivers include having necessary administrative and financial resources, managing relationships with multiple suppliers, managing inventories, billing patients and third-party payors, and monitoring new clinical developments. The Company believes that the shift from hospital-based to office-based or home-based therapy administration has created a significant opportunity, particularly in the oncology, gastroenterology, vaccine, infertility, rheumatology, pulmonary, neurology, respiratory, renal dialysis, hemophilia, sinusitis, psoriasis, cystic fibrosis and ophthalmology markets. The Company is focused primarily on these markets, but is developing business in other growing markets as well.
Oncology. The occurrence of cancer continues to grow in the United States. According to the American Cancer Society Cancer Facts and Figures 2004, in the United States, men have an approximately one in two chance of developing cancer during their lifetime, and women have a one in three chance. Also, according to the National Institutes of Health (NIH), the overall direct medical costs for cancer in the United States was estimated to be $64.2 billion in the year 2003. The principal treatments for cancer are surgery and a regimen of pharmaceutical treatments. Surgery typically involves hospitalization, but radiation and chemotherapy are increasingly being delivered in alternate site settings such as the physician office and the home.
Also, according to the American Cancer Society report, in the United States the total number of patients living with, or having a history of, cancer was estimated to be 9.6 million in 2000 and the number of new patients developing cancer each year is estimated to be 2.3 million. According to a 2003 survey conducted by Pharmaceutical Research and Manufacturers of America (PhRMA), there were 395 medicines in development for cancer. In addition, the overall incidence of cancer is expected to increase as the average age of the U.S. population continues to increase. According to the American Cancer Society report, approximately 76% of all cancers are diagnosed in people age 55 or over.
Gastroenterology. Priority operates in the gastroenterology market, principally through the sale of PEG-Intron®, Rebetol®, Pegasys®, Copegus® and Ribavirin for the treatment of hepatitis C. According to the US Department of Health and Human Services (Department of Health) in 2004, an estimated 3.9 million Americans were infected with hepatitis C, of whom 2.7 million were chronically infected. Also, according to Hepatitis Foundation International in 2004, approximately 25,000 to 30,000 new hepatitis C infections occur each year. According to the Department of Health, the incidence of hepatitis C infection has declined from its peak in the 1980s. However, the Company believes the treated portion of this population is likely to increase as awareness of hepatitis disease management programs increases. According to NIH in 2003, hepatitis C is responsible for an estimated 8,000 to 10,000 deaths annually in the United States, is one of the most important causes of chronic liver disease, and liver failure from chronic hepatitis C is one of the most common reasons for liver transplants in the United States.
Vaccine. The worldwide vaccine market was estimated to be $6.23 billion in 2001, according to Aventis Pasteur, a world leader in vaccine production. Also, according to Aventis Pasteur, more than 500 million people are immunized each year and the main vaccines sold in 2001 were flu, polio, pediatric combinations and travelers vaccines. Growth in the vaccine market is expected to be driven by the growth of combination pediatric vaccines, travelers vaccines, vaccines for adolescent protection, vaccines for the elderly and vaccines to treat chronic infectious disease and cancer.
Infertility. Infertility is an emotionally devastating disease that the Company estimates adversely affects approximately 15% of the couples in the United States that desire to have children. The Company believes
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pharmaceutical innovations involving medications for ovulation induction treatment are enabling thousands of couples to enjoy parenthood. Ovulation induction typically occurs over a one month period of time involving specialty pharmaceuticals requiring self administered injections and related medical supplies. According to the Department of Health and the Society for Assisted Reproductive Technology, there were 115,392 assisted reproductive technology cycles performed in 391 clinics during 2002, up from 107,587 cycles performed in 384 clinics during 2001.
Rheumatology. Rheumatoid arthritis (RA) is a chronic inflammatory disease that predominantly affects the joints. According to the Arthritis Foundation in 2003, RA affects 2.1 million Americans, with females two to three times more likely to be affected than males. Enbrel®, Remicade® and Humira® are the leading drugs that treat RA. According to a 2004 study done by SG Cowen, the RA market was expected to be $2.8 billion in 2004 and $4.1 billion by 2008.
Pulmonary Hypertension. Pulmonary hypertension is a disorder of the blood vessels in the lungs that causes pressure in the pulmonary artery to rise above normal levels and may become life threatening. According to The American Lung Association, 163,000 people were afflicted with pulmonary hypertension in 2000. According to NIH, it is estimated that there are 300 new cases diagnosed in the United States each year.
There are currently four drugs approved for pulmonary hypertension. They are continuous intravenous Flolan®, a synthetic form of prostacyclin, Tracleer, an oral medication, and Ventavis Inhalation Solution. The Company has an agreement with United Therapeutics Corporation to be one of three exclusive specialty distributors for the fourth, Remodulin®, which has been developed as an alternative to Flolan®. Remodulin® is a prostacyclin analogue that is administered as a continuous subcutaneous or intravenous treatment and is a life long therapy. The Company also has an agreement with CoTherix, Inc. to distribute Ventavis.
Other Pulmonary Diseases. Idiopathic pulmonary fibrosis (IPF) is a disease characterized by acute inflammation in the lung and progressive scarring that leads to a gradual loss of lung function. Actimmune®, manufactured by InterMune, is self-administered via subcutaneous injection three times a week. According to the Pulmonary Fibrosis Foundation in 2005, there are approximately 200,000 people in the United States suffering from IPF. The Company estimates that the market in the United States for the treatment of IPF exceeds $1 billion. Also, according to a 2003 article in the American Journal of Nursing, about 15,000 new cases of IPF are diagnosed annually in the United States.
On May 15, 2003, an FDA advisory panel unanimously recommended the approval of Xolair® to the FDA for the treatment of moderate to severe allergic asthma in adults and adolescents. The Company has an agreement with Genentech, Inc. and Novartis Pharmaceuticals Corporation to be a preferred distributor of Xolair® for specialty pharmacy dispensing, patient assistance product fulfillment and specialty distribution.
Neurology. Multiple sclerosis (MS) is a progressive neurological disease in which the body loses the ability to transmit messages among nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. According to the National Multiple Sclerosis Society in 2003, MS affects approximately 400,000 people in the United States and every week about 200 more people are diagnosed. There are currently three interferon products approved in the United States for treating persons with relapsing forms of MS, Avonex®, Rebif® and Betaseron®. Copaxone®, an immune modulator, and Novantrone®, an immune suppressant, also treat MS. According to a 2004 Morgan Stanley research report, the market for MS drugs in the United States was $1.8 billion in 2003 and is expected to grow to $3.8 billion by 2010.
Renal Dialysis. End stage renal disease (ESRD) is characterized by the irreversible loss of kidney function and requires kidney transplantation or routine dialysis treatment (either periodialysis or hemodialysis), which involves removing waste products and excess fluids from the blood. Hemodialysis typically utilizes various specialty pharmaceuticals and related medical supplies as part of the treatment. According to a 2003 Lehman Brothers research report, in the United States about 380,000 people were treated for ESRD in 2000, at a cost to Medicare of $12.3 billion. Also, according to the Lehman Brothers research report, by 2010 it is estimated that 661,000 ESRD patients will require treatment in the United States. The medication most frequently prescribed to hemodialysis patients is Epogen®, which stimulates the production of red blood cells, as well as calcium, iron, hepatitis vaccine and other nutrient compounds. The Company estimates that the United States market for Epogen® alone exceeds $1 billion.
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Hemophilia. Hemophilia is a genetically inherited bleeding disorder that results in a longer than normal blood clotting time for its victims due to a deficiency of blood proteins that are crucial to proper clotting. Two major disease categories exist, Hemophilia A, or Factor VIII deficiency, and Hemophilia B, or Factor IX deficiency. Hemophilia is generally treated by infusing clotting factor into the bloodstream to replace deficient proteins. According to the Centers for Disease Control in 2004, hemophilia is an inherited bleeding disorder that affects 18,000 persons, primarily males, in the United States. According to a 2002 Morgan Stanley research report, the Factor VIII hemophilia market is $2 billion and is expected to exceed $3.5 billion by 2006.
Sinusitis. Sinusitis is one of the most commonly reported chronic conditions in the United States. Chronic sinusitis is marked by repeat or long lasting sinus infections that can span three to eight weeks or continue for months and even years. According to the latest statistics from the National Institute of Health, in 2002 chronic sinusitis affected 33 million American adults. First line medical therapies for chronic sinusitis often include oral medications. If oral medications fail, second line oral medications, intranasal nebulized medications, or intravenous therapy may be prescribed. SinusPharmacy, Inc., which the Company acquired in 2003, is the sole-source provider of the SinuNEB® System, a patented intranasal nebulized therapy.
Ophthalmology. Age-Related Macular Degeneration (AMD) is a degenerative condition of the macula, or the central part of the retina in the eye. The most advanced cases of AMD result in the total loss of central vision, making many activities difficult or impossible; however, AMD does not cause complete blindness. In the United States, AMD is the leading cause of vision loss for people 55 years of age or older, and its prevalence increases in higher age populations. According to HealthLink Medical College of Wisconsin in 2004, up to 30 million people worldwide suffer from the condition, with over 200,000 new cases diagnosed in the United States each year. The Company is a preferred specialty distributor and the preferred specialty pharmacy provider of Visudyne®, a treatment for AMD. The Company estimates that the market for Visudyne® in the United States exceeds $150 million. The Company is also a specialty distributor for Macugen, another treatment for AMD.
Business Strengths
Priority believes the following represent the Companys business strengths and have been the principal factors in the Companys business success to date.
Knowledgeable Sales, Marketing and Support Staff. The Company has a well-trained, knowledgeable telesales, outside sales and sales support staff of approximately 200 full-time associates. Priority holds frequent meetings and training sessions with its suppliers to enable the sales and support staff to be well-informed about current and new biopharmaceuticals. The sales and support staff provides not only superior and knowledgeable customer service, but also promotes the sale of new products.
Clinical Expertise. The Company provides disease treatment programs to patients and physicians through its highly trained clinical staff of pharmacists, nurses and patient care coordinators. These personnel are available for ongoing consultation with the patient and the dispensing physician regarding the patients therapy and progress seven days a week, 24 hours a day. These programs are branded as disease specific Caring Paths. In order to serve the specific needs of its customers, Priority operates licensed pharmacies, one of which was the first to be accredited with commendation by ACHC (Accreditation Commission for Health Care, Inc.), which is specific to specialty pharmacies.
Broad Product Offerings to Targeted Markets. Priority sells over 5,000 SKUs of pharmaceuticals and medical supplies which enable the Company to provide one-stop shopping to its customers. Priority targets its selling efforts of this broad range of products and services to customers in alternate site settings, such as physicians offices, ambulatory surgery centers, renal dialysis clinics and patients self-administering at home. The Company continually evaluates new products that it can add to its offerings to continue to meet the needs of these specialized markets.
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Commitment to Customer Service. The Company is committed to providing superior customer service that includes shipping products ordered before 7 p.m. for delivery the next day and filling 99% of all in stock orders within one day of being ordered. Prioritys software enables its salespeople to quickly determine product availability, pricing, customer order history and billing information. In addition, Priority provides patient education, counseling and follow-up with 24-hour on-call nurses to assist its patients in better understanding and complying with their treatments.
Efficient Infrastructure. Priority has focused considerable time and expense on building an infrastructure, including computer systems and training, that enable the Company to operate efficiently and manage rapid growth. In addition, the Companys centralized approach to the distribution of its products and services maintains a low cost, very efficient model. Management also focuses on tightly controlling expenses and is constantly re-evaluating the efficiency of its operations, including purchasing and distribution.
Growth Strategy
The Companys objective is to continue to grow rapidly and enhance its market position as a leading specialty pharmacy provider and specialty distributor by capitalizing on its business strengths and pursuing the following strategy.
Continue to focus on further penetrating the core specialty distribution and pharmacy market. By focusing on the core specialty distribution and pharmacy market, the Company has targeted growth segments of the health care industry. The Company intends to increase its core specialty distribution and pharmacy market presence by expanding its product and service offerings, increasing its sales and marketing personnel and focusing on group accounts. The Company has over 7,000 customers, including physicians focusing on oncology, gastroenterology, rheumatology, pediatrics, vaccines, ophthalmology and ambulatory surgery. The Company believes that a number of physicians that order pharmaceuticals and supplies from the Company also treat patients who require patient-specific, self-administered biopharmaceuticals. The Companys information database identifies these cross-selling opportunities, and Priority believes it is well-positioned to capture incremental revenue from these customers. Priority also targets physicians who are not specialty distributors with its sales efforts. Priority also continues to expand its relationships with payors who often influence the decision on which pharmacy service provider to use.
Develop new manufacturer relationships that provide access to new products and services. By targeting chronic disease therapies that require patient-specific, self-administered biopharmaceuticals, the Company continues to expand its markets. An example is the Remodulin® therapy for patients suffering from pulmonary hypertension which was added through an agreement with United Therapeutics Corporation. Priority is one of only three specialty pharmacies that provide Remodulin® and was the lead pharmacy in handling the clinical trial patients. The Company also has an agreement with Novartis Pharmaceuticals Corporation to be a preferred specialty distributor and the preferred specialty pharmacy provider of Visudyne®. The Company also has an agreement with Genentech, Inc. and Novartis Pharmaceuticals Corporation to be a preferred distributor of Xolair® for specialty pharmacy dispensing, patient assistance product fulfillment and specialty distribution.
Continue to develop group purchasing organization (GPO) and payor networks. The Company believes that with strong GPO, physician and payor networks, the relationships with its manufacturers will be enhanced, thereby increasing the potential for alliances which could expand its products, service and geographic scope. In addition, contracts with GPOs and payors, such as PBI, Amerinet, MedAssets, Aetna, Inc. and Blue Cross/Blue Shield Association generate significant new volumes and, therefore, revenue growth. The payor relationships enable the Company to service more patients and physicians.
Enter new specialty markets. The Company continues to enter new markets. In the past several years, the Company has forged into the pulmonology, dermatology, cystic fibrosis and otolaryngology segments, adding capabilities to serve these disease states. This increases the opportunity for the Company to grow revenues and helps minimize concentrations of existing product lines.
Pursue acquisitions to complement existing product offerings and further penetrate markets. The Company believes that the highly fragmented specialty distribution industry affords it an opportunity to grow through selective acquisitions. By acquiring complementary businesses, the Company can increase its customer base, expand
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its product and geographic scope and leverage its existing infrastructure. The Freedom Drug, Physicians Formulary and InfuRx acquisitions during 2001, the HOSS acquisition in 2002, the Sinus acquisition in 2003 and the Partners In Care, HealthBridge and Integrity acquisitions during 2004 fit this criteria.
Products and Services
Priority provides a broad range of services and supplies to meet the needs of the specialty distribution market, including the office-based oncology market, outpatient renal care market, other physician office specialty markets that are high users of vaccines and ambulatory surgery centers. Priority offers value-added services to meet the specialized needs of these markets by shipping refrigerated pharmaceuticals overnight in special packaging to maintain appropriate temperatures and offering automated order entry services and customized group account distribution. Priority distributes its products from distribution centers in Sparks, Nevada and Grove City, Ohio. The Company sells over 5,000 SKUs of pharmaceuticals such as Epogen®, Aranesp® Procrit®, Neupogen®, propofol and paclitaxel and related medical supplies such as IV solutions, IV sets, gloves, needles, syringes, custom sterile procedure kits and sharps containers. Prioritys distribution centers service over 7,000 customers located in all 50 states, including office-based oncologists, renal dialysis clinics, ambulatory surgery centers and primary care physicians.
Priority believes its knowledgeable sales force provides a competitive advantage when selling into the specialty distribution market. As part of the Companys commitment to superior customer service, the Company offers its customers ease of order placement. Since a majority of customer orders are placed by telephone, the Company offers its customers a toll-free telephone number, fax line and electronic data interchange (EDI) ordering capability. The Company also offers internet ordering capabilities. Orders typically are received by the Companys telesales and sales service personnel who use PC-based computer systems to enter customer orders, and to access product information, product availability, pricing, promotions and the customers buying history. Once an order is received, it is electronically sent to the appropriate distribution center where it is filled and shipped. The Company estimates that approximately 98% of all items are shipped without back ordering, and that 99% of all in stock orders received before 7 p.m. are shipped on the same day that the order is received. See Sales and Marketing.
Priority also provides patient-specific, self-administered biopharmaceuticals and related disease treatment programs to individuals with chronic diseases. At 32 licensed pharmacies in 17 states, Priority fills patient-specific prescriptions and primarily ships them via overnight delivery in special shipping containers to maintain appropriate temperatures. These services are provided in combination with the Companys disease treatment programs, through which the Companys pharmacist and nursing staff provide education, counseling and other services to patients. Over 98% of the Companys sales relates to the sale of biopharmaceuticals.
Priority has traditionally provided disease treatment programs for hepatitis and cancer, with biopharmaceuticals that primarily consist of Interferon, a synthetic biopharmaceutical used to treat hepatitis B and C, PEG-Intron® and Pegasys®, pegulated interferons, Rebetol®, Copegus® and ribavirin, oral antivirals, and epoetin alfa, a synthetic biopharmaceutical used to treat anemia. Priority has continually added many more products, including Temodar®, an oral chemotherapy used to treat Anaplastic astrocytoma (a brain malignancy), Thalomid®, an oral product with antiangiogenesis properties used to treat a variety of cancers, Plenaxis, a prostate cancer therapy, Remodulin®, a continuous subcutaneous or intravenous treatment and life long therapy used to treat pulmonary hypertension, Remicade®, an intravenous product used to treat Crohns Disease and rheumatoid arthritis patients, Betaseron®, an injectable product used to treat patients with multiple sclerosis, Enbrel®, an injectable product used to treat patients suffering from rheumatoid arthritis, AdhesENT formulated nebulized medications for topical delivery to the sinuses for the treatment of chronic sinusitis, Visudyne®, a drug therapy for patients with some forms of age-related macular degeneration, and Gonal-F® and Follistim, two injectable products used to treat infertility.
The disease treatment programs provided by the Company offer a number of advantages to patients, physicians, third-party payors and drug manufacturers. The advantages include: (i) increasing patient compliance with the recommended therapy, thereby avoiding more costly future treatments; (ii) facilitating patient education required to prepare and administer the products; (iii) reducing the potential for patient errors in dosing or wastage of product; (iv) decreasing patient or caregiver anxiety; (v) reducing the overall cost of delivery; and (vi) collecting better outcomes data. These programs are branded as disease specific Caring Paths.
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In addition to outside selling efforts that focus on payors, the Company has telesales efforts and an outside sales force that focus on marketing to physician offices where new patient referrals occur. Upon referral, patients are contacted via telephone by the Companys intake nurses who explain the program and provide education on self-injection techniques, side effects and potential drug interactions. Following the initial prescription delivery, patients are contacted by patient care coordinators who assess patient compliance and progress, inquire regarding any potential side effects, arrange the next scheduled prescription delivery, verify the shipping address, listen to patient concerns and direct questions to the Companys clinical staff. The Companys pharmacists and registered nurses are available for ongoing consultation with the patient and the dispensing physician regarding the patients therapy and progress seven days a week, 24 hours a day.
Most parenteral, or injectable, prescriptions are prepared in sterile conditions under class 100 laminar flow hoods. Licensed pharmacists verify the prescription with the prescribing physician and recheck the prescription before shipping. In order to ensure the safe delivery of prescriptions to the patient, the Company telephones the patient several days before shipping to confirm that the patient or another person will be at home to receive the package immediately upon delivery. In addition, the Company requires the overnight delivery service to obtain a signed receipt before leaving the drugs at a residence.
Freedom Drug employs a team of healthcare professionals dedicated to womens reproductive health, offering unique and comprehensive programs tailored to the individual needs of fertility centers and their patients. Freedom Drug specializes in the delivery of fertility-related pharmaceuticals and prescription compounding. Among Freedom Drugs unique programs is the Freedom Advantage, which offers cost effective coordination of fertility-related medications and fertility-related information to payors, physicians and their patients.
With the addition of Integrity, the Company now offers specialty infusion therapy services. The addition of these services broadens the Companys range of services to now include home-based services. Integrity takes a holistic approach to specialized infusion therapy through its total patient care services. This approach is evidenced by Integritys Thrive at Home Program, where nutrition support is combined with traditional infusion therapy, distinguishing Integrity from other in-home health care providers.
With the addition of HealthBridge, the Company is now a provider of reimbursement solutions and product support to pharmaceutical manufacturers, biotechnology companies and medical device companies. The addition of these services to Prioritys portfolio complements the Companys disease treatment programs and provides a greater ability to support the core marketplace served by Prioritys specialty pharmacy and distribution services.
In August 2004, the Company and Aetna Inc. formed a new joint venture, Aetna Specialty Pharmacy, LLC, which is an Aetna-branded specialty pharmacy operation. The joint venture is owned 60% by the Company and 40% by Aetna.
Sales and Marketing
The Company employs approximately 200 full-time telesales, outside sales and sales support staff personnel. The Company strives to generate new customers and solidify existing customer relationships through frequent direct marketing contact that emphasizes the Companys broad product lines in specialty markets, competitive prices, responsive service and ease of order placement. The Company telesells to oncology clinics, physician offices, ambulatory surgery centers and dialysis centers. The Company targets larger customers with customized approaches developed by management and its key account team. The Company also links all customer databases to facilitate cross-selling efforts. The Company believes that there is a significant opportunity to provide its specialty pharmacy services to patients of physicians that currently order pharmaceuticals and supplies from Priority. Priority also continues to expand its relationships with payors who often influence the decision on which pharmacy service provider to use.
The Companys sales personnel service both in-bound and out-bound calls and are responsible for assisting customers in purchasing decisions, answering questions and placing orders. Sales personnel also initiate out-bound
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calls to market the Companys services to those customer accounts identified by the Company as being high volume accounts, high order frequency accounts or cross-selling opportunity accounts. The Companys sales personnel use advanced computer systems to enter customer orders and to access information about products, product availability, pricing, promotions and customer buying and referral history. All sales personnel work to establish long-term relationships with the Companys customers through regularly scheduled phone contact and personalized service, including direct sales calls on key customers.
Training for sales personnel is provided on a regular basis through in-service meetings, seminars and field training and is supported by print and video materials. Initial and ongoing training focuses on industry and product information, selling skills, ethics and compliance requirements and computer software skills. The Company believes that its investment in training is critical to establishing its competitive position in the marketplace.
Customers
Priority services over 7,000 customers located in all 50 states, including office-based oncologists, renal dialysis clinics, ambulatory surgery centers, primary care physicians, retina specialists and over 70,000 individuals with chronic diseases.
During 2004, 2003 and 2002, the Companys largest 20 customers accounted for approximately 11%, 11% and 11%, respectively, of the Companys net sales. Many of the Companys customers are members of a third party payors network. One third party payor, Aetna, Inc., accounted for approximately 7%, 8% and 10% of the Companys net sales in 2004, 2003 and 2002, respectively. In the future, most of these sales will be through the Companys joint venture with Aetna, Aetna Specialty Pharmacy, LLC, which is an Aetna-branded specialty pharmacy operation and is currently owned 60% by the Company and 40% by Aetna. Aetna has an option to purchase the Companys 60% interest beginning in 2008, subject to acceleration under certain circumstances. Significant declines in the level of purchases by one or more of the Companys largest customers or the loss of a significant payor could have a material adverse effect on the Companys business and results of operations. As is customary in its industry, the Company generally does not have long-term contracts with its customers. Management believes that the retention rate for the Companys customers is very favorable. However, an adverse change in the financial condition of any of these customers, including an adverse change as a result of a change in governmental or private reimbursement programs, could have a material adverse effect on the Company.
Purchasing
Management believes that effective purchasing is key to both profitability and maintaining market share. The Company has several large suppliers. Amgen accounted for approximately 10%, 11% and 11% of the Companys total net sales in 2004, 2003 and 2002, respectively. Schering Corporation accounted for approximately 3%, 10% and 16% of the Companys total net sales in 2004, 2003 and 2002, respectively. Ortho Biotech accounted for approximately 14%, 11% and 15% of the Companys total net sales in 2004, 2003 and 2002, respectively. The Company continually evaluates its purchase requirements and likely increases in manufacturer prices in order to obtain products at the most advantageous cost. It has negotiated several partnership relationships with manufacturers that offer favorable pricing, volume-based incentives and opportunities to reduce supply chain costs for both parties.
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Competition
The specialty pharmaceutical and medical supply industry is highly competitive and is experiencing both horizontal and vertical consolidation. The industry is fragmented, with several public and many small private companies focusing on different product or customer niches. Some of the Companys current and potential competitors include regional and national full-line, full-service medical supply distributors; independent specialty distributors; national full-line, full-service wholesale drug distributors that operate their own specialty distribution businesses; retail pharmacies; specialty pharmacy divisions of pharmacy benefit managers (PBMs); institutional pharmacies; hospital-based pharmacies; home infusion therapy companies; and certain manufacturers that own distributors or that sell their products both to distributors and directly to users, including clinics and physician offices. Some of the Companys competitors have greater financial, technical, marketing and managerial resources than the Company. While competition is primarily price and service oriented, it can also be affected by depth of product line, technical support systems, specific patient requirements and reputation. There can be no assurance that competitive pressures will not have a material adverse effect on the Company.
Government Regulation
As a provider of healthcare services and products, the Company is subject to extensive regulation by federal, state and local government agencies. The following are particular areas of government regulation that apply to our business.
Licensing and Registration. The Company is required to register with the United States Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA) and appropriate state agencies for various permits and/or licenses, and it also must comply with the operating and security standards of such agencies. The Companys Sparks, Nevada and Grove City, Ohio distribution centers are licensed to distribute pharmaceuticals in accordance with the Prescription Drug Marketing Act of 1987. The Sparks and Grove City locations are also licensed to distribute or dispense certain controlled substances in accordance with the requirements of the Controlled Substances Act of 1970. Similarly, the Companys pharmacy program and provider businesses are subject to licensing by the DEA as well as by the state boards of pharmacy, state health departments and other state agencies where they operate. The Companys nurses must also obtain state licenses to provide teaching services and the hands-on nursing which the Company provides to some of its patients, and the Companys pharmacists must obtain state licenses to dispense drugs. The Companys pharmacists and nurses are licensed in those states where their activity requires it. Pharmacists and nurses must also comply with professional practice rules.
The Company engages in certain mixing or reconstituting activities at its pharmacies. Due to national concerns about the sterility of compounded pharmaceuticals meant for intravenous patient use, the United States Pharmacopeia, an expert pharmacy panel that develops drug standards, adopted a wide-sweeping regulation called USP Chapter 797 Sterile Compounding in January 2004. All pharmacies that perform mixing and reconstitution of sterile pharmacy products will be expected to meet its requirements. This may increase costs as new equipment may be necessary as well as additional training and quality assurance methodology, and it may present opportunities as certain smaller pharmacies in the U.S. may decide that the cost and risk of complying with USP 797 are too great to continue their compounding activities. The Company has evaluated the requirements of USP 797 and put into place a plan to ensure compliance by all of the Companys pharmacies. The Company should be in substantial compliance with USP 797 by the middle of 2005. The expected cost of additional training, environmental testing and equipment should not be material to the Company.
On November 21, 1997, the President signed into law the FDA Modernization Act of 1997, which, among a number of other items, added a new section on pharmacy compoundingsection 503Ato the Federal Food, Drug and Cosmetic Act. In this new provision, Congress sought to clarify a gray area by identifying the circumstances in which pharmacies may compound drugs without the need for filing a New Drug Approval (NDA) application, observing the FDAs Good Manufacturing Practice (GMP) regulations or complying with certain other specific Federal Food, Drug and Cosmetic Act requirements. In particular, Congress provided that the term compounding does not include mixing or reconstituting that is done in accordance with directions contained in approved labeling provided by the manufacturer of the product.
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On April 29, 2002, the U. S. Supreme Court, reviewing a decision from the U.S. Court of Appeals for the Ninth Circuit, held the advertising and promotion provisions of Section 503A unconstitutional under the First Amendment. These advertising and promotion provisions themselves did not impact the Company. However, because the Court of Appeals had held that those provisions were not severable from the remainder of Section 503A, and because that issue had not been raised before the Supreme Court, the Courts decision invalidated Section 503A as a whole. The FDA responded on June 7, 2002 by publishing a new Compliance Policy Guide, entitled Sec. 460.200 Pharmacy Compounding (the Guide). The Guide delineates between what the FDA will consider traditional pharmacy practice to be regulated by State Boards of Pharmacy, and what the FDA will consider manufacturing of drugs to be regulated by the FDA.
Since the Guide was published, the FDA has cited it in Warning Letters to other facilities engaging in pharmacy compounding. The Company believes, based on the Guide and these Warning Letters, that as long as it continues to adhere to what the Guide specifies as traditional pharmacy practice and not the manufacturing of drugs (including, but not limited to, compounding drugs only for identified individual patients using licensed pharmacy practitioners and bulk active ingredients that are components of FDA-approved drugs or otherwise in compliance with investigational regulations), the Companys activities will be regulated under state pharmacy laws rather than under the Food, Drug and Cosmetic Act. However, there can be no assurance that future court decisions, legislation, rulemaking or other regulatory activity by the FDA concerning compounding activities of pharmacies will not have a material adverse effect on the Companys business or results of operations.
State Pharmacy Regulation. The Company distributes pharmaceuticals to all 50 states. Many of the states into which the Company delivers pharmaceuticals and controlled substances have laws and regulations that require out-of-state pharmacies to register with that states board of pharmacy or similar regulatory body. The Company has registered in every state that requires registration for the services it provides. To the extent some of these states have specific requirements for out-of-state pharmacies that apply to the Company, the Company believes that it is in compliance with them. Also, some states have proposed laws to regulate on-line pharmacies, and the Company may be subject to this legislation if it is passed.
Referral Restrictions. The Company is subject to federal and state laws which govern financial and other arrangements between healthcare providers. These laws include the federal anti-kickback statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration directly or indirectly in return for or to induce the referral of an individual to a person for the furnishing of any item or service for which payment may be made in whole or in part under Medicare or Medicaid. Many states have enacted similar statutes which are not necessarily limited to items and services for which payment is made by Medicare or Medicaid. Violations of these laws may result in fines, imprisonment and exclusion from the Medicare and Medicaid programs or other state-funded programs. Federal and state court decisions interpreting these statutes are limited, but have generally construed the statutes to apply if one purpose of remuneration is to induce referrals or other conduct prohibited by the statute.
In part to address concerns regarding the anti-kickback statute, the federal government has promulgated regulations that provide exceptions, or safe harbors, for transactions that will be deemed not to violate the anti-kickback statute. In November 1999, final regulations were adopted to clarify these safe harbors and to provide additional safe harbors. Although the Company believes that it is not in violation of the anti-kickback statute, its operations do not fit within any of the existing safe harbors. Until 1997, there were no procedures for obtaining binding interpretations or advisory opinions from the Health and Human Services Office of the Inspector General (OIG) on the application of the federal anti-kickback statute to an arrangement or its qualification for a safe harbor upon which the Company can rely. However, the Social Security Act requires the Secretary of Health and Human Services to issue written advisory opinions regarding the applicability of certain aspects of the anti-kickback statute to specific existing or proposed arrangements. Advisory opinions are binding as to the Secretary and the party requesting the opinion. The Company does not intend to request any advisory opinion regarding the Companys operations.
The OIG has issued Fraud Alerts identifying certain questionable arrangements and practices which it believes may implicate the federal anti-kickback statute. The OIG has issued a Fraud Alert providing its views on certain joint venture and contractual arrangements between healthcare providers. The OIG also has issued a Fraud Alert concerning prescription drug marketing practices that could potentially violate the federal anti-kickback
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statute, and has issued the Compliance Program Guidance for Pharmaceutical Manufacturers. Pharmaceutical marketing activities may implicate the federal anti-kickback statute because drugs are often reimbursed under the Medicaid program. According to the Fraud Alert, examples of practices that may implicate the statute include certain arrangements under which remuneration is made to pharmacists to recommend the use of a particular pharmaceutical product. In addition, a number of states have undertaken enforcement actions against pharmaceutical manufacturers involving pharmaceutical marketing programs, including programs containing incentives to pharmacists to dispense one particular product rather than another. These enforcement actions arise under state consumer protection laws which generally prohibit false advertising, deceptive trade practices and the like. Further, a number of the states involved in these enforcement actions have requested that the FDA exercise greater regulatory oversight in the area of pharmaceutical promotional activities by pharmacists. It is not possible to determine whether the FDA will act in this regard or what effect, if any, FDA involvement would have on the Companys operations.
Significant prohibitions against physician referrals were enacted by Congress in 1993. These prohibitions, commonly known as Stark II, amended prior physician self-referral legislation known as Stark I by dramatically enlarging the field of physician-owned or physician-interested entities to which the referral prohibitions apply. Effective on January 1, 1995, Stark II prohibits a physician from referring Medicare or Medicaid patients to an entity providing designated health services in which the physician has an ownership or investment interest, or with which the physician has entered into a compensation arrangement. Stark II also prohibits the entity from billing the government for services rendered pursuant to a prohibited referral. The designated health services include clinical laboratory services, radiology services, radiation therapy services and supplies, physical and occupational therapy services, durable medical equipment and supplies, parenteral and enteral nutrients, equipment and supplies, prosthetic devices, orthotics and prosthetics, outpatient prescription drugs, home health services, and inpatient and outpatient hospital services. The penalties for violating Stark II include a prohibition on payment by these government programs, civil penalties of as much as $15,000 for each violative referral and $100,000 for participation in a circumvention scheme, and exclusion from further participation in Medicare or Medicaid.
In January, 1998, the CMS published proposed regulations implementing Stark II. On January 4, 2001, CMS issued an Interim Final Rule with comment period implementing Phase I of the Stark II statute. Phase I addresses CMSs interpretation of the basic self-referral prohibition, the statutory definitions, selected compensation arrangement exceptions and certain global exceptions to the prohibition, including the in-office ancillary services exception and the prepaid health plan exception. On July 26, 2004, the OIG issued final Phase II regulations addressing the remaining compensation arrangement exceptions, the ownership and investment interest exceptions, reporting requirements and sanctions. The Company believes it is in compliance with the Stark laws and does not anticipate any negative impact by the Phase II regulations on its operations.
Since the mid-1990s, federal regulatory and law enforcement authorities have increased enforcement activities with respect to Medicare and Medicaid fraud and abuse regulations and other reimbursement laws and rules, including laws and regulations that govern the activities of many of the Companys customers. There can be no assurance that increased enforcement activities will not indirectly have a material adverse effect on the Company.
Patient Confidentiality. Various federal and state laws establish minimum standards for the maintenance of medical records and the protection of patient health information. In the course of business, the Company maintains medical records for each patient to whom it dispenses pharmaceuticals. As a result, the Company is subject to one or more of these medical record and patient confidentiality laws. Of particular significance are the Health Insurance Portability and Accountability Act of 1996 (HIPAA) security and privacy regulations. The HIPAA security regulations, which establish certain standards for assuring the physical security and integrity of electronically maintained health information, were issued as a final rule on February 20, 2003. Covered Entities as defined in the final security rule, which includes the Company, must comply with the requirements of the final security rule by April 20, 2005. The Company expects that it will be in compliance with the security standards by the April 20, 2005 deadline. The HIPAA privacy regulations, which establish standards for protecting the confidentiality and privacy of health information in any form, were issued as a final rule on December 28, 2000. On August 17, 2002, the Department of Health issued an amended final rule modifying the privacy rule standards for protecting the confidentiality of health information. The Company has complied with the final privacy rule.
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The HIPAA privacy regulations require that the Company make substantial changes to its policies, procedures, forms, employee training and information handling practices. The HIPAA security regulations require the Company to upgrade information systems hardware, software and procedures.
In addition, as part of the Administrative Simplification provision of HIPAA, final regulations were issued on August 17, 2000, governing electronic transactions involving health information. These regulations are commonly referred to as the Transactions Standards Rule. The Transactions Standards establish uniform standards to be utilized by Covered Entities in the electronic transmission of health information in connection with certain common health care financing transactions, such as health care claims. Under the Transactions Standards, any party transmitting or receiving health care transactions electronically must send and receive data in a single format, rather than the large number of different data formats currently used. The Transactions Standards apply to the Company in connection with submitting and processing health care claims and also apply to many of the Companys payors and its relationship with those payors.
The HIPAA regulations impose significant civil and criminal sanctions for violations of the rules and improper use or disclosure of patient information. The HIPAA regulations also impose criminal penalties for fraud against any health care benefit program, for theft or embezzlement involving health care and for false statements in connection with the payment of any health benefits. These HIPAA fraud and abuse provisions apply not only to federal programs, but also to private health benefit programs. The HIPAA regulations also broadened the authority of the OIG to exclude participants from federal health care programs. Although the Company does not know of any current violations of the fraud and abuse provisions of HIPAA, if the Company were found to be in violation of these provisions, the government could seek penalties against it, including exclusion from participation in government payor programs.
Reimbursement
A substantial portion of the sales of the Company is derived from third-party payors, including private insurers and managed care organizations such as HMOs and PPOs. Similar to other medical service providers, the Company experiences lengthy reimbursement collection periods as a result of third-party payment procedures. Consequently, management of accounts receivable through effective patient registration, billing, collection and reimbursement procedures is critical to financial success.
Private payors typically reimburse a higher amount for a given service and provide a broader range of benefits than governmental payors, although net revenue and gross profits from private payors have been affected by the continuing efforts to contain or reduce the costs of healthcare. A portion of the Companys revenue has been derived in recent years from agreements with HMOs, PPOs and other managed care providers. Although these agreements often provide for negotiated reimbursement at reduced rates, they generally result in lower bad debts, provide for faster payment terms and provide opportunities to generate greater volumes than traditional indemnity referrals.
In 2004, the Companys revenues from Medicare and Medicaid were approximately 2% and 3%, respectively, of the Companys total revenues. Also, due to the reliance of office-based oncologists and renal dialysis clinics on Medicare and Medicaid reimbursement, changes in such governmental programs could have a material effect on the Companys results of operations.
Because the Medicare program represents a substantial portion of the federal budget, Congress takes action in almost every legislative session to modify the Medicare program. In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also known as the Medicare Modernization Act (MMA). The MMA created a new Medicare prescription drug benefit (beginning in 2006) and, more immediately, a prescription drug card program. On January 21, 2005, the Centers for Medicare & Medicaid Services (CMS) issued final rules implementing the portions of the MMA relating to the new prescription drug benefit.
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In addition to these new programs, the MMA also made changes affecting payments for drugs under Medicares existing benefits. Principal among these latter changes was a modification in the method of calculating reimbursements for certain oncology, renal dialysis, and other drugs, from a system based on average wholesale price, or AWP, to one based on average sales price, or ASP. At least one Medicaid program has adopted, and the Company expects other Medicaid programs, some states and some private payors to adopt, those aspects of the MMA that either result in or appear to result in price reductions for drugs covered by such programs. Adoption of ASP as the measure for determining reimbursement by Medicare and Medicaid programs for the drugs the Company sells could reduce revenue and gross margins and could materially affect the Companys current AWP based reimbursement structure with its private payors.
The MMA also required the OIG to conduct studies on payments for renal dialysis drugs, and these studies could lead to additional, longer-term payment changes. Similarly, the MMA required the Secretary of Health and Human Services to conduct a demonstration project on reimbursement for dialysis services under which drugs now paid outside a composite rate would be bundled into a new type of prospective payment. The Secretarys demonstration project could lead to additional, longer-term changes in payments for dialysis drugs. At this time, the effect of the MMA on the Company is unclear. Medicare reform will continue to be a focus of Congressional activity. Therefore, legislation or regulations may be enacted in the future that may significantly modify the end stage renal dialysis program or substantially reduce the amount paid for dialysis or oncology treatments. Further, statutes or regulations may be adopted which impose additional requirements in order for the Companys customers to be eligible to participate in the federal and state payment programs. Such new legislation or regulations could adversely affect the Companys business operations.
Additionally, the Balanced Budget Act of 1997 (the Budget Act), which was enacted in August 1997 and amended by the MMA, contained numerous provisions related to Medicare and Medicaid reimbursement. While very complicated, the general thrust of the provisions dealing with Medicare and Medicaid contained in the Budget Act is intended to significantly slow the growth in Medicare spending. The Budget Act contains changes to reimbursement rates for certain Medicare and Medicaid covered services, as well as certain limitations on the coverage of such services. Laws enacted subsequent to 1997 have affected the scope and reach of the Budget Acts provisions. Although the Companys revenues in 2004 included less than 6% direct reimbursement from Medicare and Medicaid, the Budget Act may affect the Companys suppliers and customers, which in turn could have an adverse effect on the Company.
In addition, the Company expects that private payors will continue their efforts to contain or reduce healthcare costs through reductions in reimbursement rates or other cost-containment measures. The continuation of such efforts could have a material adverse effect on the Companys financial condition and results of operations.
False Claims Act. A range of federal civil and criminal laws target false claims and fraudulent billing activities. One of the most significant is the Federal False Claims Act, which prohibits the submission of a false claim or the making of a false record or statement in order to secure a reimbursement from a government-sponsored program. In recent years, the federal government has launched several initiatives aimed at uncovering practices that violate false claims or fraudulent billing laws. Claims under these laws may be brought either by the government or by private individuals on behalf of the government, through a whistleblower or qui tam action.
Network Access Legislation. A majority of states now have some form of legislation affecting a companys ability to limit access to a pharmacy provider network or remove network providers. Such legislation may require plans or others to admit any retail pharmacy willing to meet the plans price and other terms for network participation (any willing provider legislation), or may prohibit the removal of a provider from a network except in compliance with certain procedures (due process legislation) or may prohibit days supply limitations or co-payment differentials between mail and retail pharmacy providers. Many states have exceptions to the applicability of these statutes for managed care arrangements or other government benefit programs. As a dispensing pharmacy, however, such legislation benefits the Company, by ensuring the Company access to all networks in those states.
Plan Design Restrictions. Some states have legislation that prohibits a health plan sponsor from implementing certain restrictive design features. For example, some states have enacted freedom of choice legislation that entitles members of a plan to prescription drug benefits even if they use non-network pharmacies. Some states are implementing rules limiting formulary flexibility and preventing plans from changing their
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formularies during the plan year. Although the Company operates in these states, this legislation does not generally apply directly to the Company, but it may apply to some of its customers. If other states enact similar legislation, PBMs may be less able to achieve economic benefits through disease treatment services and their services may be less attractive to customers.
Certificate of Need. Many states throughout the country have certificate of need laws. These laws require a healthcare provider wishing to add or expand a certain service or purchase certain equipment to obtain state approval based upon an unmet healthcare need. Integrity Healthcare, a division of the Company, has operations in three states with certificate of need laws: Kentucky, Tennessee and South Carolina. Integrity Healthcare presently has home health certificate of need approval in approximately eight counties in Kentucky, one-third of Tennessee, and none in South Carolina. Integrity has been able to provide the full range of home infusion services at all of its locations through obtaining certificates of need or through subcontracting.
Other Regulatory Issues. Certain states have adopted, or are considering adopting, restrictions similar to those contained in the federal anti-kickback and physician self-referral laws. Although the Company believes that its operations do not violate applicable state laws, there can be no assurance that state regulatory authorities will not challenge the Companys activities under such laws or challenge the dispensing of patient-specific, self-administered biopharmaceuticals by the Company as being subject to state laws regulating out-of-state pharmacies.
The Company believes that its pharmacy practices and its contract arrangements with other healthcare providers and pharmaceutical suppliers are in compliance with these laws. To address the risks presented by such laws, the Company has implemented an ethics and corporate compliance program. There can be no assurance that such laws will not, however, be interpreted in the future in a manner inconsistent with the Companys interpretation and application.
While the Company believes that it is in substantial compliance with all existing laws and regulations stated above, such laws and regulations are subject to rapid change and often are uncertain in their application. As controversies continue to arise in the health care industry, federal and state regulation and enforcement priorities in this area may increase, the impact of which on the Company cannot be predicted. The Company can not assure you that it will not be subject to scrutiny or challenge under one or more of these laws or that any such challenge would not be successful. Any such challenge, whether or not successful, could have a material adverse effect on the Companys business and results of operations.
Employees
At January 1, 2005, the Company had approximately 1,380 full-time equivalent employees. None of the Companys employees is currently represented by a labor union or other labor organization. Approximately 18% of the employees are pharmacists or nurses. The Company believes that its relationship with its employees is good.
RISK FACTORS
The following factors, among others, could cause actual results to differ materially from those contained in forward-looking statements made in this report and presented elsewhere by management from time to time. Such factors, among others, may have a material adverse effect on our business, financial condition, and results of operations and you should carefully consider them. It is not possible to predict or identify all such factors. Consequently, you should not consider any such list to be a complete statement of all our potential risks or uncertainties. Because of these and other factors, past performance should not be considered an indication of future performance.
If we are unable to manage our growth effectively, our business will be harmed.
The Companys business has grown significantly over the past several years as a result of internal growth and acquisitions. This has placed significant demands on the Companys management team, computer and telecommunication systems, and internal controls. To meet these demands, the Company intends to continue to add new members to its management team, make investments in computer and telecommunication systems and strengthen internal controls. The Company must also continue to integrate its acquisitions to ensure retention of key employees and customers of acquired companies.
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We depend on continuous supply of our key products. Any shortages of key products could adversely affect our business.
Many of the biopharmaceutical products the Company distributes are manufactured with ingredients that are susceptible to supply shortages. In addition, the manufacturers of these products may not have adequate manufacturing capability to meet rising demand. If any products we distribute are in short supply for long periods of time, this could result in a material adverse effect on our business and results of operations.
We are highly dependent on our relationships with our suppliers and the loss of any of our key suppliers could adversely affect our business.
Any termination of, or adverse change in, our relationships with our key suppliers, or the loss of supply of one of our key products for any other reason, could have a material adverse effect on our business and results of operations. The Companys two largest suppliers accounted for the following percentages of our total net sales in 2004 respectively: Ortho Biotech: 14%; and Amgen, Inc.: 10%. We have a single source of supply for many of our key products, including the products supplied by the Companys two largest suppliers, each of which is the only manufacturer of those products. In addition, we have few long-term contracts with our suppliers. Our arrangements with most of our suppliers may be canceled by either party, without cause, on minimal notice. Many of these arrangements are not governed by written agreements.
We depend on reimbursements from third party payors and changes in reimbursement policies or efforts by payors to recoup payments already made could have an adverse effect on our revenues and results of operations.
The profitability of the Company depends in large part on reimbursement from third-party payors. In 2004, Aetna, Inc. accounted for approximately 7% of our net sales. In the future, most of these net sales will be made by our joint venture with Aetna, Aetna Specialty Pharmacy, LLC, which is an Aetna-branded specialty pharmacy operation and is currently owned 60% by the Company and 40% by Aetna. Aetna has an option to purchase the Companys 60% interest beginning in 2008, subject to acceleration under certain circumstances. The loss of a payor relationship, or an adverse change in the financial condition of a payor, could result in the loss of a significant number of patients and have a material adverse effect on our business, financial condition and results of operations. In recent years, competition for patients, efforts by traditional third-party payors to contain or reduce healthcare costs, and the increasing influence of managed care payors, such as health maintenance organizations, have resulted in reduced rates of reimbursement. If these trends continue, they could adversely affect our results of operations unless we can implement measures to offset the loss of revenues and decreased profitability. Our office-based and clinic customers seek reimbursement from third-party payors for the cost of pharmaceuticals and related medical supplies that we distribute. Changes in reimbursement policies of private and governmental third-party payors, including policies relating to the Medicare and Medicaid programs, could reduce the amounts reimbursed to these customers for our products and in turn, the amount these customers would be willing to pay for the products. Although our revenues in 2004 did not include significant amounts of reimbursement from Medicare and Medicaid, changes in those reimbursement policies affect our customers, which in turn could have an adverse effect on us.
Third-party payors also have contractual rights to audit our books and records to determine if they have overpaid us. If an audit would find that we received overpayments, we could be required, under the terms of our contractual relationship, to reimburse the payor. Subject to the outcome of the audit, we could be required to make a significant payment in order to satisfy our alleged contractual obligations. If payors seek to recoup payments already made to us, it could have a material adverse effect on