K-V Pharmaceutical Use of Cash Collateral Approved by U. S. Bankruptcy Court

K-V Pharmaceutical Company (“K-V” or “the Company”) announced that the U.S. Bankruptcy Court for the Southern District of New York, the Honorable Judge Allan L. Gropper presiding, today approved on an interim basis the Company’s request for the use of cash collateral that was made as part of the Company’s voluntary reorganization cases filed under chapter 11 of the U. S. Bankruptcy Code.
“Together with the Court’s prior approval of our First Day motions, this authorization of the use of cash collateral is another important step forward, further ensuring that K-V is able to continue operations and focus on the restructuring process,” said Greg Divis, President and CEO of K-V Pharmaceutical. “Meanwhile, reaching agreement regarding this matter with our Senior Noteholders sets the stage for continued cooperation toward the development of a plan of restructuring under which K-V will be able to emerge from chapter 11 as a stable and competitive company,” Divis concluded.
K-V and certain of its affiliates commenced cases to reorganize under chapter 11 of the U.S. Bankruptcy Code on August 4, 2012. The chapter 11 cases are being jointly administered under case number 12-13346.
As a further step along the path of its restructuring, the Office of the United States Trustee will hold a meeting to form an Official Committee of Unsecured Creditors on August 13, 2013. Final hearings on the First Day motions, certain other motions as well as a final hearing on the use of cash collateral are scheduled for August 23, 2012.

K-V Pharmaceutical Announces Updated Makena® Performance Metrics

K-V Pharmaceutical Company (the "Company" or "K-V"), today reported updated performance metrics for Makena®, the only U.S. Food & Drug Administration ("FDA") approved product indicated to reduce the risk of preterm birth in women with singleton pregnancy who have a history of a singleton spontaneous preterm birth.Makena® was launched during March of 2011. From its launch date through October 31, 2011:Approximately 7,100 vials have been shipped to Ther-Rx customers, and more than 4,700 vials have been shipped to doctors and patients;The average number of vials shipped per week to Ther-Rx customers increased 35% from the month of July to the month of October while the average number of vials shipped per week to doctors and patients increased nearly 13% during the same period;Approximately 4,300 patient referrals from over 2,700 prescribers have been made to the Makena Care Connection(TM) and the number of enrollments who have initiated treatments increased from the month of July to the month of October by nearly 16%;Approximately 2,400 patients have either initiated treatment, are in the enrollment phase or are pending insurance approval and treatment initiation;Over 200 payers, both commercial and Medicaid, have reimbursed Makena®;Contracts have been reached with four commercial insurers that cover an estimated 50 million persons;At least 17 states have reimbursed Makena® and K-V has signed Makena® rebate contracts with three states and two Managed Medicaid plans covering 5 to 6 million persons; andCurrent data indicates patient co-pays are averaging approximately $11 per injection, the same or less cost than those typically associated with compounded 17P formulations."Our commercialization efforts remain centered on communicating the important differences between FDA-approved Makena® and compounded 17P formulations," said Greg Divis, President and CEO of K-V Pharmaceutical and President of Ther-Rx. "We are actively engaging the physician and payer communities and the success of our focused outreach is evidenced by Makena®'s improving performance metrics. We believe our efforts are driving expanded access to Makena® while we are also successfully maintaining low out-of-pocket costs for patients."

K-V Pharmaceutical Co. is Today's Focus Stock on MicroStockProfit.com

MicroStockProfit.com announces an investment report featuring K-V Pharmaceutical Co. . The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.
K-V Pharmaceutical Co. (KV-A) is a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technologically-distinguished branded and generic/non-branded prescription pharmaceutical products. Its strategic goal is to become a specialty branded pharmaceutical marketing company primarily focused on women's healthcare. The Company conducts its branded pharmaceutical operations through Ther-Rx and, previously, it conducted its generic/non-branded pharmaceutical operations through ETHEX, which focused principally on technologically-distinguished generic products. In May 2010, the Company formed a wholly-owned subsidiary, Nesher, to operate as the sales and marketing company for its generic products. The Company expects to complete a divestiture of Nesher and the Company's generics business by the end of calendar year 2011.

Ex-CEO pleads guilty to misbranding drugs

The former chairman and CEO of St. Louis-based KV Pharmaceutical Co. was fined $1 million after pleading guilty Thursday to misdemeanor counts related to manufacturing oversized tablets of a pain-relief drug called morphine sulfate.

Marc S. Hermelin, 69, also was sentenced to a month in prison after pleading guilty to two federal counts of misbranding drugs. He also agreed to forfeit $900,000 to the federal government.

"FDA's drug-labeling laws and regulations are designed to ensure that Americans can safely consume effective drug products," said Patrick Holland, the agent in charge of the Food and Drug Administration's Office of Criminal Investigations. "We will continue to work with the U.S. Attorney's Office and the Department of Justice to investigate those companies and individuals who participate in the distribution of misbranded drugs."

Calls seeking comment from the company went unanswered Thursday.

KV Pharmaceutical manufactured generic prescription drugs, including morphine sulfate, a pain relief and opiate drug. Prosecutors said Hermelin decided to increase production of the drug, from an average 4.1 million daily doses in 2006 to 10.6 million in April 2008.

Later in 2008, the company shipped oversized tablets to retailers in California and Canada that were falsely labeled as having the same strength as the regular morphine sulfate tablets -- they actually had more of the active ingredient. KV also received complaints from consumers concerned about oversized and irregularly-shaped drug tablets, the U.S. Attorney's office in St. Louis said.

Prosecutors said the California morphine tablets weighed more than twice the amount they were supposed to, and the Canada morphine tablets were 65 percent stronger than the label claimed. KV's own safety assessment from May 2008 concluded that oversized morphine tablets raised potential safety concerns, including the possibility of an overdose that could cause a coma or death.

KV does not currently manufacture morphine sulfate tablets. Since March 2009, KV has been under a civil consent decree that regulates its ability to manufacture drugs.

Hermelin resigned from KV's board in November. He was removed as chief executive in December 2008 following an investigation into mismanagement by the board.

A wholly-owned subsidiary of KV, Ethex Corp., pleaded guilty in March 2010 to two felony fraud counts as part of the same investigation. Ethex was ordered to pay $27.6 million in fines and restitution.

K-V Pharmaceutical Company Announces Comprehensive Patient Assistance Program for Makena™

K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, along with its branded subsidiary, Ther-Rx Corporation, today announced the details of its patient assistance program for Makena™ -eligible patients. Makena will be available for prescribing the week of March 14. "Prior to FDA approval of Makena, women who could benefit from therapy may have faced barriers to access due to the absence of a commercially-available, FDA-approved product," said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. "We established this comprehensive patient assistance program as part of our commitment to ensure that all eligible women have access to FDA-approved Makena." The patient assistance program for Makena covers both uninsured and insured patients, and is based on income eligibility requirements. The program has been designed with the following guidelines in place: Insured patients with annual household incomes of up to $100,000 who apply for and are eligible for copay assistance will have a copay of $20 or less per injection for Makena.Uninsured patients with annual household incomes of up to $60,000 who apply for and are eligible for patient assistance will receive Makena at no cost. Uninsured patients with annual household incomes between $60,000 and $100,000 will be able to acquire Makena at a cost that is comparable to the average copay assigned by commercial insurance plans.
The patient assistance program is available as part of the services provided by the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena in one single point of contact. Because specialty injectable products like Makena are not typically carried by retail pharmacies, the prescription process for Makena will be managed by this dedicated customer support center. The services designed to support therapy for patients include: Administrative support including insurance benefit investigation and prescription fulfillment.Financial and co-pay assistance for eligible insured and uninsured patients with annual household incomes of less than $100,000.Coordination of treatment support including educational information, home health care service and scheduled treatment reminders.
"Ther-Rx recognizes the importance of ensuring that the process of prescribing and obtaining Makena be as easy as possible for healthcare providers and patients," said Divis. "We look forward to providing our customers with an outstanding level of support for Makena." The Makena Care Connection is available by calling 1-800-847-3418. Hours of operation are 8 a.m. to 9 p.m. EST, Monday-Friday.

K-V Pharmaceutical Company Announces $200 Million Private Debt Offering

K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company") announced today that it intends to offer $200 million of senior secured notes due 2015 (the "Notes") in a private placement, subject to market conditions. The Notes will be offered only to accredited investors pursuant to Regulation D under the Securities Act of 1933, as amended (the "Securities Act"). The Notes have not been registered under the Securities Act or any state or other securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements of the Securities Act and applicable state securities laws.The Company intends to use the net proceeds from the offering of the Notes to repay in full the Company's outstanding obligations under its credit agreement with U.S. Healthcare I, L.L.C. and U.S. Healthcare II, L.L.C. (including the payment of related premiums) and terminate the related future loan commitments, to establish an escrow reserve for one year of interest payments on the Notes and for general corporate purposes. This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities.

K-V Pharmaceutical Secures Financing Commitments Establishing Path Forward For Specialty Pharmaceutical Business

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has entered into an agreement with US Healthcare I, L.L.C. and US Healthcare II, L.L. C. (together, the "Lenders") affiliates of New York-based Centerbridge Partners, L.P ("Centerbridge") for a senior secured debt financing package of up to $120 million consisting of (1) a fully funded $60 million term loan (the "Bridge Loan") that will retire the previously announced $20 million loan provided by the Lenders and provide for general corporate and working capital purposes and (2) a commitment to provide a multi-draw term loan up to an aggregate principal amount of $120 million consisting of three tranches that will be available to the Company for purposes that include the retiring of the Bridge Loan, following its satisfaction of certain conditions, including the pending approval of Gestiva™ which has an U.S. Food and Drug Administration action date of January 13, 2011.

Under the terms of the Bridge Loan agreement, the Company will pay interest at an annual rate of 16.5% (5% of which shall be payable in kind) with a maturity date of March 2013. The Company has furnished as collateral substantially all assets of the Company to secure the loan. The Bridge Loan is guaranteed by certain of the Company's domestic subsidiaries and the guarantors furnished as collateral substantially all of their assets to secure the guarantee obligations.

In addition, the Company issued a stock warrant to the Lenders that grants them rights to purchase up to 9,900,000 shares of the Company's Class A Common Stock, par value $.01 per share (the "Initial Warrant"). Upon the completion of a 10-day notice period to stockholders, the Company will issue a second stock warrant that grants the right to purchase up to 2,687,511 shares of the Company's Class A Common Stock, par value $.01 per share (the "Second Warrant," and together with the Initial Warrant, the "Warrants"). All warrants issued will have an exercise price of $1.62 per share. Jefferies & Co advised the Company on the above transaction.

K-V Pharmaceutical Enters Loan Agreement In Wake Of FDA Approval

K-V Pharmaceutical Co. (KVA, KVB) has reached a $20 million loan agreement in the wake of a recent U.S. Food and Drug Administration approval as the struggling specialty-drug company seeks to recover from regulatory and compliance issues.

Class A shares were up 3.5% at $2.47 in recent trading. The stock has dropped 33% this year.

K-V had stopped manufacturing and shipping all of its products in early 2009 and recalled most already on the market as it dealt with an FDA investigation into compliance matters and management misconduct, among other issues.

But the company said last week it received FDA permission to return potassium supplement Micro-K to market following successful inspection of its facilities. It hadn't expected to be able to ship any product before the fourth quarter.

The loan agreement, which expires Jan. 31, 2011, calls for a 16.5% annual interest rate. K-V also has agreed to an exclusive two-week negotiating period with the lender over an expanded, longer-term financing pact. The party was identified in a Tuesday statement from K-V as U.S. Healthcare I LLC and U.S. Healthcare II LLC.


Read more: http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201009141014dowjonesdjonline000198&title=k-v-pharmaceutical-enters-loan-agreement-in-wake-of-fda-approval#ixzz0zZtJXlXn

K-V Pharmaceutical Company Announces Completion of U.S. Food and Drug Administration Inspection and Approval to Return its First Product to Market

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its first product to market. Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products. During the week of August 16, 2010, the FDA undertook an inspection of the Company's quality systems, manufacturing processes and facilities focusing on the first product dosage form for reintroduction by the Company into the marketplace. The inspection was successfully completed.

The Company received notification from the FDA on September 8, 2010 of approval to ship into the marketplace the first product approved under the consent decree, i.e. Potassium Chloride. The Company expects that initial shipments of its Micro-K(R)10mEq and Micro-K(R) 8mEq will begin the week of September 13, 2010. The FDA is expected to conduct additional inspections with respect to other Company products before deciding whether other products may be manufactured and marketed.

Greg Divis, President of Ther-Rx Corporation and Interim President and Chief Executive Officer of K-V Pharmaceutical Company, stated, "Today marks a significant milestone in our efforts to restore business operations at K-V. The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current Good Manufacturing Practices ("cGMP") requirements. We are committed to continuing to move K-V through further successful inspections and to obtain additional product approvals from the FDA."

K-V Pharmaceutical Company Announces the Election of New Independent Member to Board of Directors Read more: K-V Pharmaceutical Company Announces the

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that Mr. Robert Baldini was appointed as a new independent member of the Board of Directors by a unanimous vote of the directors, which also voted to increase the size of the Board to eight directors.

Mr. Joseph Lehrer, Chairman of the Board's Nominating and Corporate Governance Committee, stated, "The entire Board takes great pleasure in announcing that Mr. Robert Baldini has joined K-V as a member of its Board of Directors. Bob possesses an outstanding reputation within the pharmaceutical industry, as well as extensive knowledge and experience in sales, marketing and development of pharmaceutical products. We believe he will be an especially valuable asset to K-V as we continue to work towards receiving U.S. Food and Drug Administration approval of Gestiva(TM) and ultimately commence the launch and sales program for that product."

Mr. Baldini stated, "I am pleased to be invited to serve on the K-V Board because I want to be a part of the Company's resurgence. Over the course of my tenure as a Board member, I will utilize my background and experience in the pharmaceutical industry to assist management with respect to its current products, its launch of Gestiva(TM) following FDA approval, and the acquisition and development of other new pharmaceutical products."

K-V Pharmaceutical. Need advice/help!!

This post will be on the A share, KV-A.  As of Friday 5/8/09, it closed at $1.60. 

Here are some statistics I looked at:

Book value: $9.38

PB: 0.17

PS: 0.12

10 year average PE: $0.72 <== all 10 years were positive (impressive)

Generally healthy numbers.

At first glance, the numbers are excellent.  The only real problem I saw was $266.9M of long-term debt.  Well, the balance sheet's also a year old, but what can I do? Anyway, the long-term debt is pretty staggering. 

I found the following in their 2008 annual report:

"In May 2003, we issued $200.0 million principal amount of Notes that are convertible, under certain circumstances, into shares of our Class A Common Stock at an initial conversion price of $23.01 per share.  The Notes bear interest at a rate of 2.50% and mature on May 16, 2033. "

Later, it says:

"Holders may require us to repurchase all or a portion of their Notes on May 16, 2008, 2013, 2018, 2023, 2028, or upon a change in control, as defined in the indenture governing the Notes, at 100% of the principal amount of the Notes, plus accrued and unpaid interest to the date of repurchase, payable in cash."

The only thing holding me back from considering KV-A in real life a few weeks ago was the long-term debt.  However, I'd like to note one thing:On their March 2008 balance sheet, there was $202M short-term portion of long-term debt.  In other words, the $202M appeared in current liabilities for that quarter. 

On their June 2008 balance sheet, the $200+M moved back to long-term liabilities.  As I showed from the annual report above, the March 2008 balance sheet reflected the May 16, 2008 date in which holders of the convertible Notes could demand repurchase from the company.  This means that other than a lot of interest, the principal from these Notes cannot be forced back upon the company until May 16, 2013.  

The other problem is that the company's financial statements have only come out up to June 2008.  This is not as big a problem, if the company proves to be as profitable as it has been in the past on average.  The long-term debt is really the only thing I can see that would bring this company down.  Otherwise, it's a profitable company with good numbers.

The long-term debt won't be due till 2013 at the earliest, and the holders of the convertible bonds may not even demand the principal back.  As far as the common stock conversion goes, the stock would have to above $23.01 for the Note holders to make profit on their conversion.  That means the only likely scenarios are that either they continue to hold the Notes, or that they demand principal back.  

Am I missing something here? Am I understanding their convertible bonds incorrectly? Unless there's a major change in management, the long-term debt will not hurt.  This seems to me like a decent speculative play as part of a diversified portfolio.

Thoughts?

US FDA says Solvay enzyme drug safe, effective

* Solvay's Creon can remain on the market

* Creon only such approved drug on U.S. market

WASHINGTON, - U.S. health officials have formally approved Solvay SA's (SOLB.BR) enzyme drug Creon for adults and children with a digestive disorder resulting from conditions such as cystic fibrosis and chronic pancreatitis, the agency said on Friday.

The drug, also known by its generic name pancrelipase, treats exocrine pancreatic insufficiency, in which patients lack enzymes from the pancreas that are essential to digesting food.

Solvay Pharmaceuticals, a unit of Brussels-based Solvay SA, had been seeking FDA approval to continue to sell Creon, which is made from pig glands.

Creon and related drugs have been on the market for so long that they were never required to undergo FDA approval. But in 2004 the agency ordered companies to prove such drugs were safe and effective amid concerns that they may transmit various viruses such as influenza and hepatitis to humans.

Solvay has said it takes steps to minimize the risk of infection in manufacturing Creon, and so far it has not seen a pattern of illness. An FDA panel of outside experts in December 2008 also said there was no evidence of risk to patients.

The most common side effects in patients taking Creon include gas and upset stomach, according to the FDA. More serious risk includes a possible rare bowel disorder, known as fibrosing colonopathy, that could require surgery.

Companies selling such enzyme products have until April 2010 to win U.S. approval or else halt sales.

Other manufacturers of pig-based pancreatic enzyme drugs include K-V Pharmaceutical Co (KVa.N) unit Ethex Corp and privately-held Axcan Pharma Inc, among others. Some rivals also make versions derived from vegetables and cows.

Altus Pharmaceuticals Inc (ALTU.O) is developing a rival drug produced from microbes. (Reporting by Susan Heavey; Editing by Tim Dobbyn)