News: Sciele Pharma, Inc. Reports Results for the First Quarter of …

Sciele Pharma, Inc. (NASDAQ:SCRX):

First quarter 2008 financial results include:

— Revenues were $100.4 million, an increase of 22% over the
first quarter of 2007.

— Diluted earnings per share were $0.32 (inclusive of a non-cash
impairment charge totaling $0.03 per share) compared with
$0.36 in the first quarter of 2007.

— EBITDAS (see note (a) to the financial statements accompanying
this release), a non-GAAP measure, were $30.9 million, an
increase of 8% over the first quarter of 2007.

— Cash flow per share (see note (b) to the financial statements
accompanying this release), a non-GAAP measure, was $0.56
compared with $0.54 for the first quarter of 2007.

The Company reaffirms revenue and EPS guidance for full-year 2008:

— Full-year 2008 revenue is expected to be in the range of $447
million to $470 million.

— Full-year 2008 diluted EPS is expected to be in the range of
$1.99 to $2.11, excluding any additional potential
restructuring charges related to the conversion of Sular to
Sciele’s new Sular GEOMATRIX(TM) product, nor the potential
impact of the new $100 million new share repurchase program.

Sciele Pharma, Inc. (NASDAQ:SCRX), a specialty pharmaceutical
company, today announced revenues and earnings for the first quarter
ended March 31, 2008. Net revenues for the first quarter of 2008
increased 22% to $100.4 million from $82.3 million in the first
quarter of 2007. Diluted earnings per share (EPS) for the first
quarter of 2008 were $0.32 (inclusive of a non-cash impairment charge
totaling $0.03 per share) compared with $0.36 for the first quarter of
2007. This non-cash impairment charge is related to the Company’s
equity investment in Plethora Solutions, Ltd. Earnings before
interest, taxes, depreciation and amortization, non-cash impairment
and stock compensation expense (EBITDAS, a non-GAAP measure) were
$30.9 million in the first quarter of 2008 compared with $28.6 million
in the first quarter of 2007. Cash flow per share, also a non-GAAP
measure, was $0.56 for the first quarter of 2008 compared with $0.54
for the first quarter of 2007.

Patrick Fourteau, Chief Executive Officer of Sciele Pharma,
stated, “The first quarter of 2008 marked the launch of four new
products for Sciele: the new Sular formulation, Prandin, Fenoglide,
and Allegra ODT. Additionally, in April 2008, Sciele began marketing
our fifth new product, the Twinject epinephrine auto-injector for the
treatment of severe allergic reactions and anaphylaxis. During the
second half of 2008, we also expect to introduce, upon FDA approval,
LARx for the treatment of head lice and MetPrandin for Type II
diabetes. In addition, we will also launch a new Prenate Elite
formulation. Products in our Pediatrics, Women’s Health and Diabetes
businesses are expected to be the key growth drivers for the Company
this year.”

Gross margin as a percentage of sales was 90% in the first quarter
of 2008 compared with 87% in the first quarter of 2007. Selling,
general and administrative (SG&A) expenses increased 34% to $53.3
million in the first quarter of 2008 compared with $39.7 million in
the first quarter of 2007. The increase in selling, general and
administrative expenses was primarily due to the Company’s new
Pediatric sales force, higher commissions, royalties, and costs
associated with the launches of the new Sular formulation, Prandin and
Fenoglide. SG&A expenses decreased 5% in the first quarter of 2008
compared to the fourth quarter of 2007.

Research and development expenses were $8.8 million, or 9% of
total revenues, for the first quarter of 2008, compared with $6.0
million for the first quarter of 2007. Research and development
expenses were primarily related to the pivotal clinical trials of the
pravastatin/fenofibrate combination for the treatment of mixed
dyslipidemia and glycopyrrolate for the treatment of chronic
moderate-to-severe drooling in pediatric patients.

Depreciation and amortization increased to $8.0 million in the
first quarter of 2008 from $6.7 million in the first quarter of 2007.
This increase was primarily due to the acquisition of Alliant
Pharmaceuticals, which was completed in June 2007.

Cardiovascular and Diabetes Products

Net revenues from the Company’s Cardiovascular and Diabetes
products increased $11 million, or 19%, to $68 million for the three
months ended March 31, 2008, compared to $57 million for the three
months ended March 31, 2007. The increase was primarily due to the
growth in prescriptions for Triglide, the launch of Fenoglide, and
marketing of Prandin during the first quarter of 2008, as well as
price increases implemented during 2007.

In the second half of March 2008, the Company launched its new
Sular formulation, and as of the week ended April 25, 2008,
approximately 10% of new prescriptions had moved to the new Sular
formulation, according to IMS Health NPA data.

In the first quarter of 2008, the Company began marketing Prandin,
which was licensed from Novo Nordisk in December 2007. Prandin’s
dollarized total prescriptions increased 16% in the first quarter of
2008 over the first quarter of 2007, according to IMS Health NPA data.

In February 2008, the Company launched Fenoglide, which is
indicated for the treatment of hyperlipidemia and
hypertriglyceridemia, and is the lowest dose fenofibrate on the
market. Fenoglide utilizes LifeCycle Pharma’s Meltdose(R) technology,
which is designed to provide enhanced absorption and greater
bioavailability. Total prescriptions for the Company’s fenofibrate
family of products increased 24% in the first quarter of 2008 over the
first quarter of 2007, according to IMS Health NPA data.

Women’s Health Products

Net revenues from our promoted Women’s Health products increased
$3 million, or 20%, to $20 million for the three months ended March
31, 2008, compared to $17 million for the three months ended March 31,
2007. This increase is primarily related to the prescription growth
associated with the successful launch of Prenate DHA in the second
quarter of 2007 and price increases implemented during 2007.

The Prenate family of products has shown consistent growth,
increasing total prescriptions by 15% in the first quarter of 2008
compared with the first quarter of 2007. Total monthly prescriptions
for Prenate DHA were 40,000 in March 2008, according to IMS Health NPA
data.

Zovirax sales also contributed to the growth in Women’s Health
revenues. Zovirax’s dollarized total prescriptions increased 12% in
the first quarter of 2008 compared to the first quarter of 2007,
according to IMS Health NPA data.

Pediatric and Non-promoted Products

Net revenues from our Pediatric and non-promoted products
increased $4 million, or 42%, to $13 million for the three months
ended March 31, 2008 compared to $9 million for the three months ended
March 31, 2007. This increase is primarily due to the pediatric
products added when Sciele acquired Alliant Pharmaceuticals in the
second quarter of 2007, partially offset by lower Furadantin sales.
Sales of Furadantin were higher than normal during the three months
ended March 31, 2007, as the Company experienced delays in production
delivery during 2006 due to manufacturing issues that were resolved in
the first quarter of 2007. remeron.

Sciele continues to gain market share for Allegra Oral Suspension
and Orapred ODT. Allegra (OS) new prescription market share has
increased to 23% at the end of the first quarter of 2008 from 3% at
the end of the first quarter of 2007, according to IMS Health NPA
data. New prescription market share for Orapred ODT has grown to 5.4%
in the first quarter of 2008 from 3.9% in the first quarter of 2007,
according to IMS Health NPA data.

The recent acquisition of Twinject, epinephrine auto-injector,
from Verus Pharmaceuticals, the licensing of Allegra ODT from
sanofi-aventis, and the launch upon FDA approval of LARx, a new
prescription treatment for head lice, are expected to provide future
revenue growth in the Pediatric product line. In the second quarter of
2008, the Company intends to add approximately 40 sales
representatives to its Pediatric sales team in conjunction with the
Twinject acquisition and the expected launch of LARx, expanding to
approximately 140 Pediatric sales representatives.

Product Pipeline

The Company’s product pipeline includes seven products: three are
under review at the FDA and four are currently in Phase III trials.
Sciele has launched five new products thus far in 2008, and expects to
launch three new products during the second half of 2008: MetPrandin
for Type 2 diabetes, upon FDA approval; LARx for the treatment of head
lice, upon FDA approval; in addition the Company will launch a new
Prenate Elite formulation. The continued introduction of new products
from Sciele’s pipeline is expected to be a key driver of the Company’s
future growth.

On April 21, 2008, the FDA accepted Addrenex Pharmaceuticals’
505(b)(2) New Drug Application (NDA) for CloniBID to treat
hypertension, and assigned a Prescription Drug User Fee Act (PDUFA)
date of December 19, 2008. Upon FDA approval, Sciele expects to launch
this product in early 2009. The Company licensed CloniBID and Clonicel
from Addrenex Pharmaceuticals - CloniBID for the treatment of
hypertension and Clonicel for attention deficit/hyperactivity disorder
(ADHD). CloniBID and Clonicel are both 12-hour, sustained-release
formulations of clonidine hydrochloride. The patient enrollment for
the Phase III trials using Clonicel for ADHD was initiated in October
2007. We expect to complete the Phase III clinical trials for this
indication in the second half of 2008.

The FDA has assigned a PDUFA date of July 15, 2008, for the LARx
NDA. Upon FDA approval, LARx will be the first prescription medication
that kills head lice by asphyxiation instead of utilizing a neurotoxic
pesticide.

Novo Nordisk’s NDA for MetPrandin is currently under review at the
FDA, with a PDUFA date of June 15, 2008, and, upon FDA approval,
Sciele expects to launch this product in the U.S. during the second
half of 2008. MetPrandin further expands Sciele’s product line in the
growing Type II diabetes market.

Additionally, in September 2007, Sciele completed enrollment of
patients in a Phase III safety trial utilizing a liquid formulation of
glycopyrrolate to treat chronic, moderate-to-severe drooling in
pediatric patients. This condition often results from cerebral palsy,
as well as from other neurological disorders. The Company expects to
file an NDA with the FDA in mid-2008. Glycopyrrolate received an
orphan drug designation from the FDA, which provides seven years of
marketing exclusivity after FDA approval.

In October 2007, the Company completed enrollment of patients in a
Phase III clinical trial using pravastatin and fenofibrate to treat
mixed dyslipidemia. The Phase III clinical trial is comparing the
efficacy of the combination of pravastatin and fenofibrate versus
pravastatin or fenofibrate alone. The Company expects to have the
efficacy data from this study in the second half of 2008.

Also in October 2007, Plethora Solutions initiated Phase III
clinical trial patient enrollment for PSD502 for the treatment of
premature ejaculation. PSD502 is a unique, proprietary, rapidly
absorbed formulation of two, well-established local anesthetics,
lidocaine and prilocaine, dispensed in a metered dose spray. The
efficacy studies are expected to be completed in the second half of
2008. Sciele acquired from Plethora Solutions the rights to market and
sell this product in the U.S. in May of 2007.

Financial Strength

As of March 31, 2008, the Company had $166 million in cash, cash
equivalents and marketable securities. During the first quarter of
2008, the Company repurchased $10 million, or 528,598 shares, of its
common stock through its share repurchase program. On April 25, 2008
Sciele terminated its existing share repurchase program and adopted a
new share repurchase program, authorizing the repurchase of up to $100
million of its outstanding shares of common stock over the next 12
months. The Company’s target is to repurchase over 10% of its
outstanding common shares. Sciele’s strong balance sheet and cash
flows ensure that the Company will still have sufficient financial
resources to execute its business plan.

Guidance for Full-Year 2008

Sciele reaffirms its full-year revenue and EPS guidance for 2008,
anticipating revenue to be in the range of $447-$470 million, and
diluted EPS within a range of $1.99-$2.11 per share. The guidance
for 2008 assumes an R&D expenditure rate of approximately 8% of
revenues and does not include any unapproved products or any potential
additional restructuring charges related to the new Sular conversion,
nor the potential impact of the new $100 million share repurchase
program.

Conference Call

Sciele Pharma will host a conference call on Wednesday, April 30,
2008, beginning at 4:30 p.m. Eastern Time to discuss its financial
results. Analysts, investors, and other interested parties are invited
to participate by visiting the Company’s website, www.sciele.com, and
entering the Investor Relations page. You may also dial in to the
conference call. The dial-in numbers are (888) 668-1645 for domestic
callers and (913) 312-0946 for international callers. All callers
should use passcode 7933154 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 the call promptly.

Sciele Pharma, Inc. Background

Sciele Pharma, Inc. is a pharmaceutical company specializing in
sales, marketing and development of branded prescription products
focused on the therapeutic areas of Cardiovascular, Diabetes, Women’s
Health and Pediatrics. The Company’s Cardiovascular and Diabetes
products treat patients with high cholesterol, hypertension, high
triglycerides, unstable angina and Type 2 diabetes; its Women’s Health
products are designed to improve the health and well-being of women
and mothers and their babies; and its Pediatrics products treat
allergies, asthma, coughs and colds, and attention deficit and
hyperactivity disorder (ADHD). Founded in 1992 and headquartered in
Atlanta, Georgia, Sciele Pharma employs more than 900 people. The
Company’s success is based on placing the needs of patients first,
improving health and quality of life, and implementing its business
platform - an Entrepreneurial Spirit, Innovation, Execution
Excellence, Simplicity, and Teamwork.

Safe Harbor Statement

This press release contains forward-looking statements 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 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 of 1995. These risks include, without limitation:

We may not attain expected revenues and earnings. If we are
unsuccessful in obtaining or renewing third party payor contracts for
our products, we may experience reductions in sales levels and may
fail to reach anticipated sales levels. If demand for our products
exceeds our initial expectations or the ability of our suppliers to
provide demand-meeting quantities of product and samples, our future
ability to sell these products could be adversely impacted. The
potential growth rate for our promoted products may be limited by
slower growth for the class of drugs to which our promoted products
belong and unfavorable clinical studies about such class of drugs. We
will not realize anticipated sales if our products and our licensors’
products do not receive regulatory approval.

We may encounter problems in the manufacture or supply of our
products, for which we depend entirely on third parties. Strong
competition exists in the sale of our promoted products, which could
adversely affect expected growth of our promoted products’ sales or
increase our costs to sell our promoted products. We may not be able
to protect our competitive position for our promoted products from
patent infringers. If generic competitors that compete with any of our
products are introduced, our revenues may be adversely affected.

Certain of our products have experienced manufacturing issues. If
the issues recur and cannot be resolved, our ability to acquire
product for sale and sampling will be adversely affected. We may incur
unexpected costs in integrating new products into our operations.

We may be unable to develop or market line extensions for our
products or, even if developed, obtain patent protection for our line
extensions; further, 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. If these risks occur, our financial results could be
adversely affected.

If we have difficulties acquiring new products or rights to market
new products from third parties, our financial results could be
adversely impacted. Our licensor/supplier can terminate our rights to
commercialize Nitrolingual and the 60mg dose size of this product has
not yet met our expectation.

We may not experience the beneficial results of our acquisitions
that we expect to receive, and the acquired products may not meet our
sales expectations.

We depend on a small senior management group, the departure of any
member of which would likely adversely affect our business if a
suitable replacement member could not be retained.

An adverse interpretation or ruling by one of the taxing
jurisdictions in which we operate could adversely impact our operating
results. An adverse judgment in the pending patent litigation or in
the securities class action litigation in which we and certain current
and former directors and executive officers are defendants could have
a material adverse effect on our financial results and liquidity.

Our business is subject to increasing government price controls
and other healthcare cost containment measures. Side effects or
marketing or manufacturing problems with our products could result in
product liability claims which could be costly to defend and could
result in the withdrawal or recall of products from the market which
would adversely affect our business. We may be found noncompliant with
applicable federal, state or international laws, rules or regulations
which could result in fines and/or product recalls or otherwise cause
us to expend significant resources to correct such non-compliance.

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 substantially reduced sales, substantially
and adversely impacting our financial results. 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).

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.

Some unforeseen difficulties may occur.

The above are some of the principal factors that could cause
actual results to differ materially from those described in the
forward-looking statements included above. 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.
SCIELE PHARMA, INC.
Condensed Consolidated Statement of Operations
(Unaudited, in thousands, except per share amounts)

For the Quarter Ended
March 31,
———————
2008 2007
———– ———
Net revenues $ 100,438 $ 82,257

Operating costs and expenses:
Cost of revenues 10,383 11,053
Selling, general and administrative 53,344 39,695
Depreciation and amortization 8,031 6,671
Research and development 8,780 5,981
———– ———
Total operating costs and expenses 80,538 63,400
———– ———

Operating income 19,900 18,857
Other income (expense), net (2,810) 827
———– ———

Income before provision for income taxes 17,090 19,684
Provision for income taxes 5,544 6,686
———– ———

Net income $ 11,546 $ 12,998
=========== =========

Net income per common share:
Basic $ 0.33 $ 0.37
=========== =========
Diluted $ 0.32 $ 0.36
=========== =========

Weighted average common shares outstanding:
Basic 35,352 35,170
=========== =========
Diluted 35,798 36,288
=========== ========= SCIELE PHARMA, INC.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

March 31, December 31,
2008 2007
——— ————
ASSETS
Current assets:
Cash, cash equivalents and marketable
securities $165,800 $188,288
Accounts receivable, net 79,920 71,709
Inventories 25,412 26,270
Other 55,782 60,381
——— ————
Total current assets 326,914 346,648
——— ————

Property and equipment, net 35,456 29,676

Other assets:
Intangibles, net 449,039 416,365
Other 16,810 23,979
——— ————
Total other assets 465,849 440,344
——— ————

Total assets $828,219 $816,668
========= ============

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 27,722 $ 34,031
Accrued expenses 31,816 26,490
——— ————
Total current liabilities 59,538 60,521
——— ————

Long-term liabilities:
Convertible debt 325,000 325,000
Other 8,067 6,150
——— ————
Total liabilities 392,605 391,671
——— ————

Stockholders’ equity:
Common stock 36 36
Additional paid-in capital 267,273 272,334
Retained earnings 184,512 172,966
Accumulated other comprehensive income
(loss) 548 (2,832)
Treasury stock (16,755) (17,507)
——— ————
Total stockholders’ equity 435,614 424,997
——— ————

Total liabilities and stockholders’
equity $828,219 $816,668
========= ============ SCIELE PHARMA, INC.

Reconciliation of EBITDAS (a)
(Unaudited, in thousands)

For the Quarter Ended
March 31,
———————
2008 2007
———- ———
Operating income, as reported (GAAP) $ 19,900 $18,857
Add: Stock-based compensation expense 3,001 3,055
Add: Depreciation and amortization 8,031 6,671
———- ———
Earnings before interest, taxes, depreciation,
amortization and stock-based compensation
expense $ 30,932 $28,583
========== =========

(a) The Company believes that earnings before interest and other
income/expense, taxes, depreciation and amortization, non-cash
impairment and stock-based compensation expense (EBITDAS) is a
meaningful non-GAAP financial measure as an earnings-derived
indicator that may approximate operating cash flow. EBITDAS, as
defined and presented by the Company, may not be comparable to
similar measures reported by other companies.

Reconciliation of Cash Flow Per Share (b)
(Unaudited)

For the Quarter Ended
March 31,
———————
2008 2007
———- ———
Diluted net income per share, as reported (GAAP) $ 0.32 $ 0.36
Add: Stock-based compensation expense, net
of taxes 0.06 0.06
Add: Depreciation and amortization, net of
taxes 0.15 0.12
Add: Impairment on equity investments 0.03 –
———- ———

Cash flow per share, net of taxes $ 0.56 $ 0.54
========== =========

(b) The Company believes that cash flow per share is a meaningful non-
GAAP financial measure as it is utilized by the financial community
in evaluating the Company. Cash flow per share, as defined and
presented by the Company as diluted net income per share before
stock-based compensation expense, net of taxes, depreciation and
amortization, net of taxes, and impairment on equity investments may
not be comparable to similar measures reported by other companies.
*T

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