Accredo Health, Inc. Announces First Quarter Results and Reaffirms Fiscal 2005 Estimates.MEMPHIS Memphis, city, ancient Egypt Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo. , Tenn. -- Accredo Health, Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ACDO ACDO Air Carrier District Office ACDO Assistant Command Duty Officer ) today reported results for its first quarter ended September 30, 2004. Revenues for the quarter increased 24% to $416,126,000 compared to $334,984,000 for the same period in fiscal 2004. Net earnings decreased 27% to $12,856,000, or $0.26 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, for the quarter ended September 30, 2004 compared to $17,508,000, or $0.36 per diluted share, for the same period in fiscal 2004. As previously announced, the Company expensed approximately $4.4 million ($2.7 million net of tax) in unamortized debt issuance costs associated with the replacement and expansion of its Senior Credit facility during the quarter ended September 30, 2004. Excluding the charge, diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of would be $0.32 for the quarter ended September 30, 2004. David D. Stevens, Accredo's chairman and chief executive officer remarked, "We are encouraged by the continued revenue growth both on a sequential and year over year basis. This increase is driven by growth in both our core and recently added product lines. In addition, we are pleased with the integration of our recent acquisition of Hemophilia hemophilia (hē'məfĭl`ēə,–fēl`yə), genetic disease in which the clotting ability of the blood is impaired and excessive bleeding results. Resources of America, Inc. (HRA HRA Health Reimbursement Arrangement HRA Health Risk Assessment HRA Housing and Redevelopment Authority HRA Human Resources Administration HRA Health Reimbursement Account HRA Housing Revenue Account ) and its contribution in the September quarter. Consistent with the recent reductions to our fiscal 2005 estimates, we continue to face pressure on the gross margin line due to declining reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. levels, particularly related to government payors. Furthermore, our current quarter revenue mix includes more products with a lower margin profile than our historical book of business. We continue to work diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d to influence and improve the outcome of the proposed reimbursement changes pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to Remodulin(R), Flolan(R) and blood clotting factor blood clotting factor Coagulation factor, see there , and expect to have further information before the end of calendar 2004." Stevens further commented, "The initial transfer of patients from our expanded relationship with Medco Health Solutions Medco Health Solutions, Inc. (NYSE: MHS) is a leading pharmacy benefit manager (PBM) company based in Franklin Lakes, New Jersey. The current chairman is David Snow. The company formed in August 2003 as a spinoff from Merck & Co.. , Inc. (Medco) has progressed favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. and is nearing completion. Based on the results of the September 2004 quarter, Medco revenues for fiscal 2005 are in line to meet or exceed our expectations. The seven new products launched since April 2003, which represent approximately one-third of our total product line offerings, continue to grow at or above our expectations. In addition, we have significantly increased our investment in the seasonal launch of Synagis(R) this year to take advantage of market opportunities. We will maintain our focus on expanding market share in the therapies we serve and solidifying so·lid·i·fy v. so·lid·i·fied, so·lid·i·fy·ing, so·lid·i·fies v.tr. 1. To make solid, compact, or hard. 2. To make strong or united. v.intr. our position as one of the country's premier specialty pharmacy providers." Joel R. Kimbrough, Accredo's chief financial officer, added, "We are pleased with the continued overall revenue growth, which will be supplemented in the next two quarters with revenue from the seasonal drug Synagis(R) for the treatment of RSV RSV respiratory syncytial virus; Rous sarcoma virus. RSV abbr. respiratory syncytial virus RSV 1 Respiratory syncytial virus, see there 2 Rous sarcoma virus, see there in infants. In addition, the full impact of the Medco business and our recent acquisition was not realized in the current quarter. As a result of the expected decrease in government and commercial payor reimbursement levels, primarily in the PAH PAH, PAHA aminohippuric acid. PAH abbr. para-aminohippuric acid PAH 1 Polycyclic aromatic hydrocarbon, see there 2. Pulmonary artery HTN and IVIG IVIG Intravenous immunoglobulin, see there product lines, coupled with the first full-quarter impact of the reduced reimbursement levels for hemophilia products from MediCal, we experienced declines this quarter in gross profit and net income margins. We continue to monitor and proactively address legislative and marketplace changes during this climate of changing reimbursement levels." Mr. Kimbrough continued, "We are reaffirming our previously announced fiscal year 2005 revenues and earnings estimates of $1.85 billion to $1.90 billion in revenues and $1.45 to $1.53 in diluted earnings per share, inclusive of inclusive of prep. Taking into consideration or account; including. the $4.4 million ($2.7 million net of tax) write-off of unamortized debt issuance costs. Despite the level of change that is occurring in our industry, the fundamentals of our business remain strong. As previously announced, these estimates assume no new indications for current product lines (including our newest product APOKYN(TM)), potential new product lines or possible future acquisitions and are based upon our current estimates for reimbursement rates." In addition to the previous discussions, we are providing the following questions and answers related to our operating results and our on-going business: Q1) What new developments have occurred pertaining to the effect of the Medicare Prescription Drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, , Improvement and Modernization modernization Transformation of a society from a rural and agrarian condition to a secular, urban, and industrial one. It is closely linked with industrialization. As societies modernize, the individual becomes increasingly important, gradually replacing the family, Act of 2003 (MMA (Microcomputer Managers Association, Inc.) A membership organization with chapters throughout the U.S. that was devoted to educating personnel responsible for personal computers. It disbanded in 1996. Mma - A fast Mathematica-like system, in Allegro CL by R. Fateman, 1991. ) on the reimbursement for Remodulin and Flolan, two of the Company's treatments for patients with Pulmonary Arterial arterial /ar·te·ri·al/ (-al) pertaining to an artery or to the arteries. ar·te·ri·al adj. 1. Of or relating to one or more arteries or to the entire system of arteries. 2. Hypertension? A1) As previously announced, since January 1, 2004, the effective date of the MMA, the DME (Distributed Management Environment) A network monitoring and control protocol defined by the Open Software Foundation (now The Open Group). DME was not widely used. DME - Distributed Management Environment regional carriers (DMERCs) have established payment rates for the 10 mg Remodulin(R) vial vial a small bottle. size and the 0.5 mg vial size of Flolan(R) at rates that are below our acquisition cost of the drugs. In addition, one regional DMERC DMERC Durable Medical Equipment Regional Carrier is currently paying all Remodulin(R) vial sizes at the same rate per mg as that of the 10 mg vial, thus reducing our reimbursement for all Medicare recipients of Remodulin(R) in that region. Since the new rates went into effect, we have appealed claims in this one region, and we were hopeful that the DMERC would retroactively ret·ro·ac·tive adj. Influencing or applying to a period prior to enactment: a retroactive pay increase. [French rétroactif, from Latin correct this situation. We were also hopeful that the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) would retroactively increase the reimbursement rates for Flolan(R) and Remodulin(R). The Company and the manufacturer of Remodulin(R), United Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. Corporation, separately met with CMS to discuss these issues. In addition, numerous discussions have occurred since these meetings. CMS has not definitively responded to our request for changes in the rates. However, a change in those rates is possible, and we believe that CMS has the authority to initiate, and is currently considering, such a change under the guidelines set forth in the MMA. As more definitive information becomes available, we will evaluate our long-term strategy with regard to these products. Q2) What is the latest information on MediCal reimbursement for blood clotting factor for fiscal 2005? A2) Effective June 1, 2004, MediCal, the California state Medicaid program, began implementation of a new reimbursement methodology for hemophilia blood clotting factor. Under this methodology, providers will be reimbursed a rate of ASP plus 20% for all factor products. At the time of our fiscal 2004 year-end earnings release, we had not received payment from MediCal on blood clotting factor dispensed dis·pense v. dis·pensed, dis·pens·ing, dis·pens·es v.tr. 1. To deal out in parts or portions; distribute. See Synonyms at distribute. 2. To prepare and give out (medicines). 3. on or after June 1, 2004. During the September 2004 quarter, however, we received payments from MediCal for blood clotting factor at levels that are substantially consistent with our previous estimates. Q3) What is the effect of the MMA on the reimbursement for hemophilia clotting factor clot·ting factor n. Any of various plasma components involved in the clotting of blood, including fibrinogen, prothrombin, thromboplastin, and calcium ion. Also called coagulation factor. ? A3) Under the MMA, there are major changes in the Medicare payment Noun 1. medicare payment - a check reimbursing an aged person for the expenses of health care medicare check bank check, check, cheque - a written order directing a bank to pay money; "he paid all his bills by check" rates for blood clotting factor beginning in 2005. Currently, Medicare payment for blood clotting factor furnished by pharmacies and physician offices continues to be at 95% of AWP AWP Awaiting Parts (military equipment status) AWP Average Wholesale Price AWP Annual Work Plan AWP Associated Writing Programs AWP Amusement with Prizes AWP Any Willing Provider AWP Aerial Work Platform in 2004. Under Medicare Part B, the Company receives 80% of this amount directly from Medicare and the remaining 20% is the patient's co-payment obligation. Effective January 1, 2005, the Company will be paid for blood clotting factor based on the new ASP methodology. We expect that the resulting payment rates will be lower than the current rates for these products. Congress has directed CMS to make a separate payment to the entity that provides blood clotting factor to a Medicare beneficiary for items and services related to the furnishing of such products. The amount of this separate payment is capped so that the total of the ASP payment rate and the separate payment amount cannot exceed 95% of AWP. In the recently issued fee schedule proposed rule, CMS proposed a separate payment amount of $0.05 per unit of blood clotting factor. We believe that the proposed separate payment amount is inadequate for the service level requirements of the Medicare beneficiary with hemophilia. A 60-day comment period for this proposed rule commenced on its release date. We provided comments to CMS on the proposed rule in September 2004, and expect CMS to release a final rule during November 2004. Our previously revised fiscal 2005 estimates assume that the separate payment of $0.05 per unit of blood clotting factor goes into effect, along with the ASP payment methodology, on January 1, 2005, and CMS makes no change in its proposed rule. Q4) What is the Company's outlook for the fiscal 2005 Synagis(R) season? A4) In the September 2004 quarter, we experienced sales of Synagis(R) above those levels obtained during the same quarter last year. As previously reported, we continue to expect to achieve revenue growth from Synagis(R) in fiscal 2005 greater than the rate of growth applicable to the overall market for that product. We incurred costs of approximately $1.6 million in the September quarter related to this season's Synagis(R) launch. As a reminder, sales of Synagis(R) primarily occur in the second and third quarters of our fiscal year. Q5) Why did gross profit margins Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. decrease to 17.7% in the September 2004 quarter compared to 22.7% achieved in the same quarter last year and to the 20.7% achieved in the June 2004 quarter? A5) For the September 2004 quarter, gross profit margins declined to 17.7% compared to 22.7% in the same quarter last year. We also experienced a decrease in gross profit margins from 20.7% in the June 2004 quarter to 17.7% in the September 2004 quarter. These declines are primarily a result of reductions in reimbursement amounts from government and commercial payors in the September 2004 quarter as compared to the relevant quarters in our last fiscal year. These reductions primarily relate to our hemophilia (specifically products reimbursed by MediCal), PAH and IVIG product lines. The decrease is also due to changes in our payor mix, and changes in the product mix derived from our expanded relationship with Medco. With regard to IVIG, we continue to face reimbursement pressure from managed care. We expect our overall gross margin percentage to be in the 16% to 17% range in the second and third quarters of fiscal 2005. The anticipated decrease from the 17.7% gross margin percentage achieved in the September 2004 quarter can be attributed to sales of the seasonal drug Synagis(R), which has a lower gross margin than the composite gross margin of all our products, coupled with various reimbursement changes discussed above. Q6) Why did interest expense (net) increase to $7.3 million in the current quarter from $2.3 million in the quarter ended September 30, 2003 and $1.8 million in the quarter ended June 30, 2004? A6) Current quarter interest expense (net) includes the write-off of approximately $4.4 million in unamortized debt issuance costs associated with the replacement and expansion of the Company's Senior Credit facility. Upon the closing of the expanded facility (now at $550 million capacity), the Company increased its borrowings to $375.0 million. The borrowings were primarily used to fund the acquisition of HRA that occurred during the September 2004 quarter. Amounts borrowed under the previous Senior Credit facility were approximately $178.4 million at June 30, 2004, and $190.6 million at September 30, 2003. Q7) Why did cash flow provided by operating activities increase to $32.3 million in the quarter ended September 30, 2004 from $9.1 million in the quarter ended June 30, 2004 and $7.5 million in the quarter ended September 30, 2003? A7) The increase in cash flow provided by operating activities in the September 2004 quarter is primarily attributable to the timing of the payment of certain accounts payable, accrued expenses Accrued Expense An accounting expense recognized in the books before it is paid for. It is a liability, usually current. These expenses are typically periodic and documented upon a company's balance sheet due to the high probability of collection. and tax obligations of the Company. In addition, the growth in accounts receivable accounts receivable n. the amounts of money due or owed to a business or professional by customers or clients. Generally, accounts receivable refers to the total amount due and is considered in calculating the value of a business or the business' problems in paying from June 30, 2004, to September 30, 2004, was lower than the sequential revenue growth, as evidenced by a three day reduction in day's sales outstanding. This is driven in part by the affect of the expanded Medco relationship. We estimate that cash flow provided by operating activities will range from $70 to $75 for the fiscal year ended June 30, 2005. As previously announced, the Company's conference call to discuss the first quarter results is scheduled for Monday, November 1, 2004, at 9:00 a.m. CST CST abbr. 1. Central Standard Time 2. convulsive shock treatment CST Central Standard Time Noun 1. . The conference call will be web-cast live on the Accredo Health, Incorporated web site. Interested parties may access the web-cast at www.accredohealth.com beginning at 9:00 a.m. CST on November 1, 2004. A replay of the call will be available, and there will also be a playback of the conference call available over the Internet beginning approximately one hour after the end of the conference call. The replay of the call will be available until November 24, 2004 at 5:00 p.m. CST. To access the replay call, dial 402-220-2491 and enter the code 26803110. The Internet playback option will be archived on the Company's website for 21 days. To access the Internet playback, go to www.accredohealth.com. In addition to historical information, certain of the statements in the preceding paragraphs, particularly those anticipating future financial performance, business prospects and growth and operating strategies constitute forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Such statements may be identified by words such as anticipate, believe, estimate, expect, intend, predict, hope or similar expressions. Such statements, which include estimated financial information or results and the quoted comments of Mr. Stevens and Mr. Kimbrough above, are based on management's current expectations and are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements, including, without limitation, the loss of a biopharmaceutical relationship, our inability to sell existing products, difficulties integrating acquisitions, the impact of pharmaceutical industry regulation, the difficulty of predicting FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and other regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities approvals, the regulatory environment and changes in healthcare policies and structure, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the ability to obtain products from suppliers, reliance on strategic alliances, the ability to expand through joint ventures and acquisitions, the ability to maintain pricing arrangements with suppliers that preserve margins, the need for and ability to obtain additional capital, the seasonality and variability of operating results, the Company's ability to implement its strategies and achieve its objectives and the risks and uncertainties described in reports filed by Accredo with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation, cautionary statements under the heading "Risk Factors" made in Accredo's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for its year ended June 30, 2004.
Accredo Health, Incorporated
Condensed Consolidated Statements of Income
(amounts in thousands, except share data)
(Unaudited)
Three Months Ended
September 30
2004 2003
Net patient revenue $ 406,856 $ 326,039
Other revenue 8,665 8,397
Equity in net income of joint ventures 605 548
-----------------------
Total revenues 416,126 334,984
Cost of sales 342,491 258,897
-----------------------
Gross profit 73,635 76,087
General & administrative 35,983 34,552
Bad debts 5,600 7,174
Depreciation and amortization 3,839 2,955
-----------------------
Income from operations 28,213 31,406
Interest expense, net (7,281) (2,276)
Minority interest in consolidated subsidiary (207) (482)
-----------------------
Net income before income taxes 20,725 28,648
Provision for income taxes 7,869 11,140
-----------------------
Net income $ 12,856 $ 17,508
=======================
Earnings per share:
Basic $ 0.26 $ 0.37
Diluted $ 0.26 $ 0.36
Weighted average shares outstanding:
Basic 48,653,474 47,848,126
Diluted 49,093,243 48,554,127
Condensed Consolidated Balance Sheets
(amounts in thousands)
(Unaudited)
September 30, June 30,
2004 2004
Cash & cash equivalents $ 81,596 $ 42,743
Accounts receivable, net 342,476 325,642
Inventories 145,542 128,323
Other current assets 49,939 52,370
Fixed assets, net 42,535 41,283
Other assets 578,499 407,821
-----------------------
Total assets $ 1,240,587 $ 998,182
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Current liabilities $ 223,003 $ 192,504
Long-term debt 370,312 174,866
Other liabilities 29,165 28,869
Stockholders' equity 618,107 601,943
-----------------------
Total liabilities and stockholders' equity $ 1,240,587 $ 998,182
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Condensed Consolidated Statements of Cash Flow
(amounts in thousands)
(Unaudited)
Three Months Ended
September 30
2004 2003
Net cash provided by operating activities $ 32,263 $ 7,456
Net cash used in investing activities (191,100) (1,894)
Net cash provided by (used in) financing
activities 197,690 (4,447)
-----------------------
Increase in cash and cash equivalents $ 38,853 $ 1,115
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