First Horizon Announces Results for the First Quarter Ended March 31, 2005 and Provides 2005 Guidance.ALPHARETTA, Ga. -- First Horizon Pharmaceutical Corporation (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 :FHRX):
First Quarter 2005 results include:
-- Net revenues of $41.0 million, an increase of 28% over first
quarter 2004
-- Net income of $7.6 million, an increase of 50% over first
quarter 2004
-- Diluted earnings per share of $0.19 versus $0.13 cents diluted
earnings per share for first quarter 2004
-- Earnings before interest, taxes, depreciation and amortization
(EBITDA, a non GAAP measure) of $15.8 million, an increase of
28% over first quarter 2004
Guidance for second quarter 2005 and full year 2005:
-- Second Quarter 2005 guidance
-- Net revenues of between $48 million and $50 million
-- Diluted earnings per share of between $0.18 and $0.20
-- Full Year 2005 guidance
-- Net revenues of between $205 million and $215 million
-- Diluted earnings per share of between $0.90 and $0.96
First Horizon Pharmaceutical Corporation (NASDAQ:FHRX), a specialty pharmaceutical company, today announced results for the quarter ended March 31, 2005. Net revenues were $41.0 million compared with $32.0 million for the quarter ended March 31, 2004. Net income for the quarter ended March 31, 2005, was $7.6 million, or $0.19 per diluted share, compared with net income of $5.0 million, or $0.13 per diluted share for the quarter ended March 31, 2004. Cost of revenues was $7.2 million for the quarter ended March 31, 2005, producing gross margins of 82%. Selling, general and administrative expenses were $17.7 million for the first quarter of 2005 compared with $13.9 million for the first quarter of 2004. First Horizon's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and President, Patrick Fourteau, commented, "We are pleased with our first quarter performance, which has been driven by solid growth of our promoted products. This is largely due to increased detailing on Sular(R), Nitrolingual(R) and the Prenate(R) line, which was rendered possible by the stopping of the promotion of Robinul(R) and the Tanafed(TM) line (due to generic competition). This growth is coupled with continued prudent expense management. Additionally, we are quite excited about the opportunity afforded us by the launch of OptiNate(TM) at the end of the first quarter of 2005 and the launch of Fortamet(R) and Altoprev(R), which is taking place in the second quarter of 2005." Cardiology Products Net revenues of the Company's Cardiology products, which include Sular (nisoldipine) and Nitrolingual (nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate. ), were $19.5 million, or 48% of total sales, for the first quarter of 2005 compared with $14.5 million, or 45% of total sales, for the first quarter of 2004. Sales of Fortamet (metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus. met·for·min n. ) and Altoprev (lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with ) commenced in April 2005. New prescriptions of Sular increased 25% and total prescriptions increased 19% for the first quarter of 2005 compared with the first quarter of 2004 (Source: IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. Health's National Prescription Audit Plus (TM) data). New prescriptions of Nitrolingual rose 4% and total prescriptions of Nitrolingual increased 3% for the first quarter of 2005 compared with the first quarter of 2004 (Source: IMS Health's National Prescription Audit Plus data). In March 2005, the Company completed its acquisition of the worldwide rights to Fortamet and Altoprev from Andrx Corporation. Fortamet is a patented, once-a-day treatment for Type 2 diabetes type 2 diabetes n. See diabetes mellitus. , and competes in the approximately $6 billion oral diabetes market (based on prescriptions according to IMS Health's National Prescription Audit Plus data). Altoprev is a patented once-a-day treatment for cholesterol, and competes in the approximately $15 billion statin stat·in n. Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol. market (based on prescriptions according to IMS Health's National Prescription Audit Plus data). During the first quarter, the Company paid Andrx $50 million and will pay up to $35 million in additional purchase price when Andrx achieves certain defined manufacturing service levels and delivers certain quantities of Altoprev. Women's Health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. Products Net revenues of the Women's Health products, which include the Prenate line and Ponstel(R) (mefenamic acid mefenamic acid /me·fe·nam·ic ac·id/ (mef?ah-nam´ik) a nonsteroidal antiinflammatory drug used to treat or prevent pain, inflammation, dysmenorrhea, and vascular headache. mef·e·nam·ic acid n. ), were approximately $12.6 million for the quarter ended March 31, 2005, compared with $3.3 million for the quarter ended March 31, 2004 for the Prenate line and Ponstel. The Robinul line and the Tanafed line are no longer promoted. Prenate Elite(TM), the only prescription prenatal vitamin with Metafolin(R), captured a 13.4% market share of new prescriptions and 13.2% market share of total prescriptions as of March 2005 (Source: IMS Health's National Prescription Audit Plus data). In late March 2005, the Company launched OptiNate, a premium prescription prenatal vitamin with an innovative, all-natural, vegetarian-sourced omega-3 fatty acid omega-3 fatty acid n. Any of various polyunsaturated fatty acids that are found primarily in fish, fish oils, vegetable oils, and leafy green vegetables, and that seem to reduce the risk of stroke and heart attack. , docosahexaenoic acid docosahexaenoic acid /do·co·sa·hexa·eno·ic ac·id/ (do-ko?sah-hek?sah-e-no´ik) an omega-3, polyunsaturated, 22-carbon fatty acid found almost exclusively in fish and marine animal oils. , commonly referred to as DHA DHA docosahexaenoic acid. DHA, n.pr See acid, docosahexaenoic. . OptiNate, which represents the Company's first line addition to Prenate Elite, will compete in the Essential Fatty Acids Essential fatty acids Sources of fat in the diet, including omega-3 and omega-6 fatty acids. Mentioned in: Nutritional Supplements (EFA EFA essential fatty acid. ) segment of the prescription prenatal vitamin market. Stock Repurchases During the first quarter of 2005, First Horizon repurchased a total of 127,169 shares of its common stock at an average cost of $16.44 per share, or $2.1 million. 2005 Outlook Second Quarter 2005 - Management believes that growth in the second quarter of 2005 will be driven by the increased size of the Company's sales force, the continuing success of its leading products, principally Sular, Nitrolingual Pumpspray, and its Prenate line, as well as sales of its new products, Fortamet, Altoprev and OptiNate. First Horizon expects second quarter 2005 revenues to be in the range of $48 million to $50 million and 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 to be in the range of $0.18 to $0.20. Full Year 2005 - First Horizon expects full year 2005 revenues to be in the range of $205 million to $215 million and diluted earnings per share to be in the range of $0.90 to $0.96. Conference Call First Horizon will host a conference call on Thursday, April 28, 2005, beginning at 5:00 p.m. Eastern Daylight Time to discuss the financial results. Analysts, investors and other interested parties are invited to participate by visiting the Company's website, www.fhrx.com, and entering the Investor Relations Investor relations The process by which the corporation communicates with its investors. page. You may also dial in to the conference call. The dial-in numbers are (800) 599-9795 for domestic callers and (617) 786-2905 for international callers. All callers should use passcode 96257336 to gain access to the conference call. Please plan to dial-in or log on at least ten minutes prior to the designated start time so management can begin promptly. First Horizon Background First Horizon Pharmaceutical Corporation is a specialty pharmaceutical company that markets and sells prescription products with a primary focus on cardiology and women's health. First Horizon has a portfolio that now includes 14 branded prescription products of which five are currently actively promoted to high-prescribing physicians through its nationwide marketing and sales force of approximately 360 representatives. First Horizon anticipates adding approximately 100 sales representatives to promote Fortamet and Altoprev. First Horizon's web site address is: www.fhrx.com. Please visit First Horizon's website for full prescribing information on First Horizon's products. 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. Statement This press release contains forward-looking statements (in addition to historical facts) that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these forward-looking statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by 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. These risks include, without limitation: --We may not attain expected revenues and earnings; --Our operating results will be substantially dependent upon the success of Fortamet and Altoprev so that any factor adversely affecting Fortamet and Altoprev could have a material adverse effect on our sales and profits; --Altoprev is currently experiencing manufacturing issues. If the issues cannot be resolved, this would impact our ability to acquire the product for sale and sampling; --We may incur unexpected costs in integrating Fortamet and Altoprev into our operations; --Our acquisition of Fortamet and Altoprev requires adjustments to our sales force, which we may not be able to complete successfully or timely in order to achieve targeted sales of Fortamet and Altoprev; --If we are unsuccessful in obtaining third party payor contracts for Altoprev and Fortamet, we may experience reductions in sales levels; --The potential growth rate for Fortamet and Altoprev may be limited by slower growth for the class of drugs to which Fortamet and Altoprev belong and unfavorable clinical studies about such class of drugs; --Strong competition exists in the sale of drugs that treat diabetes and cholesterol, which could adversely affect expected growth of Fortamet and Altoprev sales or increase our costs to sell Fortamet and Altoprev; --The potential growth rate for Sular may be limited by slower growth for the class of drugs to which Sular belongs and the ability of our sales representatives to influence prescribing habits of physicians; --Sales of our Prenate Elite and OptiNate products may not be at the levels that we anticipate; --We may not be able to protect our competitive position for Prenate Elite from patent infringers; --Sales of our Tanafed products have been adversely affected by the introduction of competitive products, and an issued 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. notice may cause us to incur increased expenses and adversely affect our ability to continue to market and sell our Tanafed products; --Introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory Obsolete Inventory Term that refers to inventory that is at the end of its product life cycle and has not seen any sales or usage for a set period of time usually determined by the industry. This type of inventory has to be written down and can cause large losses for a company. which would adversely affect our operating results; --Our supplier can terminate our rights to commercialize Nitrolingual and the smaller size of this product has not met our expectation; --A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in reduced sales; --If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them; --We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels) or trade levels of inventory; --An adverse judgment in the securities class action litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. in which we and certain directors and executive officers are defendants could have a material adverse effect on our results of operations and liquidity; --An adverse judgment in our infringement action with Breckenridge Pharmaceutical, Inc. with respect to our Tanafed products could result in the invalidation of our Tanafed patents, cause us to lose market share for Tanafed products and result in a loss of earnings and profits from Tanafed sales; --If our products under development fail in clinical studies, if we fail to obtain, or encounter difficulties in obtaining, regulatory approval for new products or new uses of existing products, or if our development agreements are terminated, we will have expended significant resources for no return; --If the FDA does not approve certain labeling for the cardiovascular product we have licensed from SkyePharma, then our sales of that product may be restricted; --Our business and products are highly regulated. The regulatory status of some of our products makes these products subject to increased competition and other risks, and we run the risk that we, or third parties on whom we rely, could violate the governing regulations; --If generic competitors that compete with any of our products are introduced our revenues may be adversely affected; and --Some unforeseen difficulties may occur. This list is intended to identify some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included herein. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission. Important Safety Information Fortamet Fortamet is indicated as an adjunct to diet and exercise to lower blood glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence . Fortamet can be used concomitantly with a sulfonylurea sulfonylurea /sul·fo·nyl·urea/ (sul?fo-nil-u-re´ah) any of a class of compounds that exert hypoglycemic activity by stimulating the islet tissue to secrete insulin; used to control hyperglycemia in patients with type 2 diabetes mellitus or insulin to improve glycemic Glycemic The presence of glucose in the blood. Mentioned in: Cholesterol, High glycemic pertaining to the level of glucose in the blood. control in adults. Fortamet is indicated in patients 17 years of age and older as either monotherapy or in combination therapy. Fortamet is contraindicated in patients with renal disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg or renal dysfunction, congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. requiring chronological treatment, metabolic acidosis Metabolic Acidosis Definition Metabolic acidosis is a pH imbalance in which the body has accumulated too much acid and does not have enough bicarbonate to effectively neutralize the effects of the acid. , and know allergy to metformin. The most common side effects Side effects Effects of a proposed project on other parts of the firm. for Fortamet include diarrhea, nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. . Important Safety Information: Lactic acidosis Lactic acidosis A serious condition caused by the build up of lactic acid in the blood, causing it to become excessively acidic. Lactic acid is a by-product of glucose metabolism. is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Fortamet Extended-Release Tablets; when it occurs it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus diabetes mellitus Disorder of insufficient production of or reduced sensitivity to insulin. Insulin, synthesized in the islets of Langerhans (see Langerhans, islets of), is necessary to metabolize glucose. In diabetes, blood sugar levels increase (hyperglycemia). and whenever there is significant tissue hypoperfusion and hypoxemia hypoxemia /hy·pox·emia/ (hi?pok-sem´e-ah) deficient oxygenation of the blood. hy·pox·e·mi·a n. Insufficient oxygenation of arterial blood. . Lactic acidosis is characterized by elevated blood lactate Lactate A salt or ester of lactic acid (CH3CHOHCOOH). In lactates, the acidic hydrogen of the carboxyl group has been replaced by a metal or an organic radical. Lactates are optically active, with a chiral center at carbon 2. levels (greater than 5 mmol/L), decreased pH, electrolyte disturbances with an increased anion gap anion gap n. The difference between the sum of cations and anions found in plasma or serum. anion gap method used to evaluate a patient's acid-base status; based on the observation that the sum of blood cations (sodium, potassium, , and an increased lactate/pyruvate ratio. When metformin is implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. as the cause of lactic acidosis, metformin plasma levels greater than 5 ug/mL are generally found. Fortamet is contraindicated in patients with renal disease or renal dysfunction (e.g. as suggested by serum creatine creatine /cre·a·tine/ (kre´ah-tin) an amino acid occurring in vertebrate tissues, particularly in muscle; phosphorylated creatine is an important storage form of high-energy phosphate. levels greater than or equal to 1.5 mg/dL in males, greater than or equan to 1.4 mg/dL in females), congestive heart failure requiring pharmacologic treatment, known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to metformin, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Fortamet should be avoided in patients with impaired hepatic function or excessive alcohol intake (chronic or acute). See full prescribing information on the Company's website. Altoprev Therapy with Altoprev should be a component of multiple risk facto intervention in those individuals with dyslipidemia who ar at risk for atherosclerotic vascular disease atherosclerotic vascular disease Atherosclerosis, see there . Altoprev should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower Total-C and LDL-C LDL-C low-density-lipoprotein cholesterol to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Altoprev should not be taken by pregnant or lactating lac·tate 1 intr.v. lac·tat·ed, lac·tat·ing, lac·tates To secrete or produce milk. [Latin lact women or those with a known allergy to lovastatin or hypersensitivity to any component of this medication. The most frequent side effects include abdominal pain, muscles aches and diarrhea. All patients should report promptly to their physician any unexplained muscle pain tenderness or weakness. Lovastatin therapy should be discontinued immediately if myopathy myopathy /my·op·a·thy/ (mi-op´ah-the) any disease of muscle.myopath´ic centronuclear myopathy myotubular m. is diagnosed or suspected. Myopathy Warning: Lovastatin, like other inhibitors of HMGCOA reductase reductase /re·duc·tase/ (-tas) a term used in the names of some of the oxidoreductases, usually specifically those catalyzing reactions important solely for reduction of a metabolite. , occasionally causes myopathy manifested as muscle pain. Myopathy sometimes takes the form of rhabdomyolysis rhabdomyolysis /rhab·do·my·ol·y·sis/ (-mi-ol´i-sis) disintegration of striated muscle fibers with excretion of myoglobin in the urine. rhab·do·my·ol·y·sis n. with or without acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. secondary to myoglobinuria, and rare fatalities have occurred. Important Safety Information: Altoprev is contraindicated in patients who are hypersensitive hy·per·sen·si·tive adj. Responding excessively to the stimulus of a foreign agent, such as an allergen; abnormally sensitive. hy to any component of this medication; in patients with active liver disease or with unexplained, persistent serum transaminase transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase. trans·am·i·nase n. See aminotransferase. elevation; and in patients who are pregnant or nursing. Most frequent adverse events considered related to Altoprev were nausea, abdominal pain, insomnia, dyspepsia dyspepsia: see indigestion. , headache, asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory asthenia and myalgia myalgia /my·al·gia/ (mi-al´jah) muscular pain.myal´gic epidemic myalgia see under pleurodynia. my·al·gia n. . See full prescribing information on the Company's website.
FIRST HORIZON PHARMACEUTICAL CORPORATION
Condensed Consolidated Statement of Operations
(Unaudited, in thousands, except per share amounts)
For the Quarter Ended
March 31,
---------------------
2005 2004
---------- ----------
Net revenues $ 40,957 $ 32,018
Operating costs and expenses:
Cost of revenues 7,169 5,575
Selling, general and administrative 17,685 13,851
Depreciation and amortization 4,363 4,131
Research and development 265 181
---------- ----------
Total operating costs and expenses 29,482 23,738
---------- ----------
Operating income 11,475 8,280
Other income, net 20 93
---------- ----------
Income before provision for income taxes 11,495 8,373
Provision for income taxes 3,907 3,326
---------- ----------
Net income $ 7,588 $ 5,047
========== ==========
Net income per common share:
Basic $ 0.21 $ 0.14
========== ==========
Diluted $ 0.19 $ 0.13
========== ==========
Weighted average common shares outstanding:
Basic 36,066 35,745
========== ==========
Diluted 43,505 38,632
========== ==========
FIRST HORIZON PHARMACEUTICAL CORPORATION
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
March 31, Dec. 31,
2005 2004
--------- ---------
ASSETS
Current assets:
Cash and cash equivalents $ 20,904 $ 36,586
Marketable securities 112,617 160,636
Accounts receivable, net 24,192 23,833
Inventories 30,547 15,824
Other current assets 15,431 16,438
--------- ---------
Total current assets 203,691 253,317
--------- ---------
Property and equipment, net 5,300 5,110
Other assets:
Intangibles, net 276,553 229,953
Other assets 10,046 10,104
--------- ---------
Total other assets 286,599 240,057
--------- ---------
Total assets $495,590 $498,484
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 19,272 $ 14,569
Accrued expenses 7,982 20,508
--------- ---------
Total current liabilities 27,254 35,077
--------- ---------
Long-term liabilities:
Convertible debt 150,000 150,000
Other long-term liabilities 5,162 4,998
--------- ---------
Total liabilities 182,416 190,075
--------- ---------
Stockholders' equity:
Common stock 36 36
Additional paid-in capital 286,690 288,335
Retained earnings 50,903 43,315
Accumulated other comprehensive income (loss) (1,265) (87)
Treasury stock (23,190) (23,190)
--------- ---------
Total stockholders' equity 313,174 308,409
--------- ---------
Total liabilities and stockholders' equity $495,590 $498,484
========= =========
FIRST HORIZON PHARMACEUTICAL CORPORATION
Reconciliation of EBITDA (a)
(Unaudited, in thousands)
For the
Quarter
Ended
March 31,
2005
---------
Net income as reported (GAAP) $ 7,588
Less: Other income, net (20)
Add: Provision for income taxes 3,907
Add: Depreciation and amortization 4,363
---------
Earnings before interest, taxes, depreciation
and amortization $ 15,838
=========
(a) The Company believes that EBITDA is a meaningful non-GAAP
financial measure as an earnings-derived indicator that
approximates cash flow. EBITDA, as defined and presented by the
Company, may not be comparable to similar measures reported by
other companies.
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