ST. LOUIS, Feb. 9, 2012 /PRNewswire/ -- K-V
Pharmaceutical Company (the "Company") (NYSE: KVa/KVb) today
reported updated performance metrics for Makena®.
Makena® was launched during March of 2011. From its
launch date through January 31,
2012:
- Approximately 7,900 vials have been shipped to Ther-Rx
customers of which approximately 6,500 vials have been distributed
to doctors and patients. This is an increase of approximately
600 vials shipped to customers and 1,600 vials shipped to doctors
and patients since November
2011;
- As part of Ther-Rx's commitment to patient access, we have also
provided approximately 1,200 additional vials at little or no
patient out-of-pocket cost through our patient assistance program
for use by patients who have demonstrated financial need;
- Approximately 6,000 patient referrals from over 3,500
prescribers have been made to the Makena Care Connection®, an
increase of approximately 1,200 patients and 500 prescribers since
November 2011;
- Approximately 3,700 patients have either initiated treatment,
are in the enrollment phase or are pending insurance approval and
treatment initiation, an increase of more than 900 patients since
November 2011;
- Over 250 payers, both commercial and Medicaid, have reimbursed
Makena® and at least 19 states have reimbursed Makena®; and
- Current data indicates patient co-pays are averaging
approximately $10 per injection, the
same or less cost than those typically associated with compounded
17P formulations.
"We continue to advance our commercialization strategy for
Makena® by actively engaging the medical and payer communities on
the differences between FDA-approved Makena® and unapproved
compounded 17P formulations," said Greg
Divis, President and CEO of K-V Pharmaceutical and President
of Ther-Rx. "Our efforts are driving improved performance
metrics and we are intensely focused on continuing to grow our
market share."
Fiscal 2012 Form 10-Q and Investor Conference Call
The Company will be filing its fiscal 2012 third quarter Form
10-Q with the U.S. Securities & Exchange Commission (SEC) after
the close of market today. The Company will host an investor
conference call on Friday, February 10,
2012 at 8:30 a.m. EST to
discuss the information contained in the Form 10-Q as well as
provide a general update on other company matters. Participants can
listen to the conference call by dialing 866-843-0890 and providing
code 4088697. To access the live web cast of the conference call,
please go to the investor relations portion of the Company's
website under "Conference Calls" at www.kvpharmaceutical.com.
Please log-in or dial-in at least 10 minutes prior to the start
time to ensure a connection.
A replay of the call will also be available for seven days by
calling 877-344-7529 and providing code 10009958. An archived
version of the webcast will be accessible for 30 days at
www.kvpharmaceutical.com.
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a specialty branded pharmaceutical
company with a primary focus in the area of women's
healthcare. As such, we are committed to advancing the
health of women across all the stages of their lives.
For further information about K-V Pharmaceutical Company, please
visit the Company's corporate Website at
www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking Statements
This press release contains various forward-looking statements
within the meaning of the United States Private Securities
Litigation Reform Act of 1995 (the "PSLRA") and which may be based
on or include assumptions concerning our operations, future results
and prospects. Such statements may be identified by the use of
words like "plan," "expect," "aim," "believe," "project,"
"anticipate," "commit," "intend," "estimate," "will," "should,"
"could," "potential" and other expressions that indicate future
events and trends.
All statements that address expectations or projections about
the future, including, without limitation, statements about product
launches, governmental and regulatory actions and proceedings,
market position, revenues, expenditures and the impact of the
recall and suspension of shipments on revenues, and other financial
results, are forward-looking statements.
All forward-looking statements are based on current expectations
and are subject to risk and uncertainties. In connection with the
PSLRA's "safe harbor" provisions, we provide the following
cautionary statements identifying important economic, competitive,
political, regulatory and technological factors, among others, that
could cause actual results or events to differ materially from
those set forth or implied by the forward-looking statements and
related assumptions. Such factors include (but are not limited to)
the following:
(1)
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our
ability to continue as a going concern, as discussed in Note
3—"Going Concern and Liquidity Considerations" in the Notes to the
Consolidated Financial Statements (Unaudited) included in Part I,
Item 1 of our Quarterly Report on Form 10-Q for the fiscal quarter
ended September 30, 2011;
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(2)
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risks
associated with the introduction and growth strategy related to the
Company's Makena® product, including:
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(a)
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the impact
of competitive, commercial payor, governmental (including Medicaid
program), physician, patient, public or political responses and
reactions, and responses and reactions by medical professional
associations and advocacy groups, on the Company's sales,
marketing, product pricing, product access and strategic
efforts;
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(b)
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the
possibility that the benefit of any period of exclusivity resulting
from the designation of Makena® as an orphan drug may not be
realized as a result of U.S. Food and Drug Administration's (the
"FDA") decision to decline to take enforcement action with regards
to compounded alternatives;
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(c)
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the Center
for Medicare and Medicaid Services' ("CMS") policy regarding
Medicaid reimbursement for Makena®, and the resulting coverage
decisions for Makena® by various state Medicaid and commercial
payors;
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(d)
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the
satisfaction or waiver of the terms and conditions for our
continued ownership of the full U.S. and worldwide rights to
Makena® set forth in the previously disclosed Makena® acquisition
agreement, as amended from time to time, including $107.5 million
of remaining scheduled payments by us for those rights as of
December 31, 2011; and
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(e)
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the number
of preterm births for which Makena® may be prescribed, its safety
and side effects profiles and acceptance of pricing;
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(3)
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the
possibility of delay or inability to obtain FDA approvals of
Clindesse® and Gynazole-1® and the possibility that any product
relaunch may be delayed or unsuccessful;
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(4)
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risks
related to compliance with various agreements and settlements with
governmental entities including those discussed in Item 1 (b)—
"Discontinuation of Manufacturing and Distribution; Product
Recalls; and the FDA Consent Decree" in the Company's Form 10-K/A
for the fiscal year ended March 31, 2011 (the "Fiscal 2011 Form
10-K/A) or in our Quarterly Report on Form 10-Q for the fiscal
quarter ended September 30, 2011, including:
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(a)
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the
consent decree between the Company and the FDA and the Company's
suspension in 2008 and 2009 of the production and shipment and the
nationwide recall of all of the products that it formerly
manufactured, as well as the related material adverse effect on our
revenue, assets, liquidity and capital resources;
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(b)
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the
agreement between the Company and the Office of Inspector General
of the U.S. Department of Health and Human Services ("HHS OIG") to
resolve the risk of potential exclusion of the Company from
participation in federal healthcare programs;
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(c)
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our
ability to comply with the plea agreement between a now-dissolved
subsidiary of the Company and the U.S. Department of Justice;
and
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(d)
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our
ability to comply with the Settlement Agreement dated December 7,
2011 with the United States resolving certain claims under the Qui
Tam provisions of the False Claims Act, which could result in
significant penalties including exclusion from participation in
federal healthcare programs;
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(5)
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the
availability of raw materials and/or products manufactured for the
Company under contract manufacturing agreements with third
parties;
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(6)
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risks that
the Company may not ultimately prevail in, or that insurance
proceeds, if any, will be insufficient to cover potential losses
that may arise from, litigation discussed in Note 16—"Commitments
and Contingencies—Litigation and Governmental Inquiries" of the
Notes to the Consolidated Financial Statements (Unaudited) in Part
I, Item 1 of our Quarterly Report on Form 10-Q for the fiscal
quarter ended September 30, 2011, including:
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(a)
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the series
of putative class action lawsuits alleging violations of the
federal securities laws by the Company and certain
individuals;
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(b)
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product
liability lawsuits;
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(c)
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lawsuits
pertaining to indemnification and employment agreement obligations
involving the Company and its former Chief Executive Officer;
and
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(d)
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challenges
to our intellectual property rights by actual or potential
competitors and challenges to other companies' introduction or
potential introduction of generic or competing products by third
parties against products sold by the Company;
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(7)
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the
possibility that our current estimates of the financial effect of
previously announced product recalls could prove to be
incorrect;
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(8)
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risks
related to the Company's highly leveraged capital structure
discussed in Part I, Item 2— "Management's Discussion and Analysis
of Financial Condition and Results of Operations—Liquidity and
Capital Resources" of our Quarterly Report on Form 10-Q for the
fiscal quarter ended September 30, 2011, including:
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(a)
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the risk
that the maturities of our debt obligations may be accelerated due
to our inability to comply with covenants and restrictions
contained in our loan agreements;
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(b)
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restrictions on the ability to increase our revenues
through certain transactions, including the acquisition or
in-licensing of products; and
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(c)
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risks that
future changes in the Board of Directors may lead to an
acceleration of the maturities of the Company's debt;
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(9)
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the risk
that we may not be able to satisfy the quantitative listing
standards of the New York Stock Exchange, including with respect to
minimum share price and public float; and
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(10)
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the risks
detailed from time to time in the Company's filings with the
Securities and Exchange Commission ("SEC"). This discussion is not
exhaustive, but is designed to highlight important factors that may
impact our forward-looking statements.
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Because the factors referred to above, as well as the statements
included in Part I, Item 1A—"Risk Factors," of our Annual Report on
Form 10-K/A for the fiscal year ended March
31, 2011, and Part II, Item 1A—"Risk Factors," and Part I,
Item 2—"Management's Discussion and Analysis of Financial Condition
and Results of Operations" of our Quarterly Report on Form
10-Q for the fiscal quarter ended September
30, 2011, could cause actual results or outcomes to differ
materially from those expressed in any forward-looking statements
made by us or on our behalf, you should not place undue reliance on
any forward-looking statements. All forward-looking statements
attributable to us are expressly qualified in their entirety by the
cautionary statements in this "Cautionary Note Regarding
Forward-Looking Statements" and the risk factors that are included
under Part I, Item 1A of the Fiscal 2011 Form 10-K/A for the fiscal
year ended March 31, 2011, and Part
II, Item 1A—"Risk Factors" in this Report, as supplemented by our
subsequent SEC filings. Further, any forward-looking statement
speaks only as of the date on which it is made and we are under no
obligation to update any of the forward-looking statements after
the date of this Report. New factors emerge from time to time, and
it is not possible for us to predict which factors will arise, when
they will arise and/or their effects. In addition, we cannot assess
the impact of each factor on our future business or financial
condition or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements.
SOURCE K-V Pharmaceutical Company