UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): August 5, 2013
K-V PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
Delaware 1-9601 43-0618919 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.)
16640 Chesterfield Grove Rd., Suite 200
Chesterfield, MO
63005
(Address of principal executive offices)
(Zip Code)
(314) 645-6600
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act. |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Item 7.01 Regulation FD Disclosure.
On August 5, 2013, Ther-Rx Corporation, a women’s health-focused pharmaceutical company and subsidiary of K-V Pharmaceutical Company, issued a press release announcing that Clindesse® is now available for prescribing. A copy of the press release is attached hereto as Exhibit 99.1
This Current Report on Form 8-K (including Exhibit 99.1 hereto and any information contained therein) shall not be deemed to be an admission as to the materiality of any information required to be disclosed solely by reason of Regulation FD. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibits are furnished as part of this report:
Exhibit Number | Description | |
99.1 |
Press Release dated August 5, 2013, issued by Ther-Rx Corporation |
The Company will post this Form 8-K on its Internet website at www.kvph.com. References to the Company’s website address are included in this Current Report on Form 8-K only as inactive textual references and the Company does not intend them to be active links to the website. Information contained on the website does not constitute part of this Current Report on Form 8-K.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K 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 the product launches, the impact of the Company’s Chapter 11 proceedings, governmental and regulatory actions and proceedings, market position, revenues, expenditures and the impact of recalls and suspensions of shipments on revenues, adjustments to the financial statements, the filing of amended filings with the Securities and Exchange Commission (the “SEC”) 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 with regard to the Company 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):
(1) the ability of the Company and the other Debtors to continue as a going concern;
(2) the ability of the Debtors to comply with the milestones in the Debtors’ debtor in possession financing agreement or the Stock Purchase and Backstop Agreement
(3) the ability of the Debtors to obtain approval of any motions filed in the Bankruptcy Court, or obtain confirmation of the Plan by the Bankruptcy Court;
(4) the ability of the Company and the other Debtors to satisfy the conditions contained in the Plan or consummate the Plan;
(5) the risks associated with one or more of the counterparties to the Stock Purchase and Backstop Agreement, the Share Purchase Agreement and exit financing commitments failing to consummate the transactions contemplated by such documents;
(6) objections that may be raised with respect to the Plan by various creditors, equity holders and other constituents of the Debtors’ and the Bankruptcy Court’s treatment of such objections;
(7) the effects of the Bankruptcy Cases on the Company and the other Debtors and the interests of various creditors, equity holders and other constituents;
(8) the effects of rulings of the Bankruptcy Court in the Bankruptcy Cases and the outcome of the cases in general;
(9) the length of time the Company and the other Debtors will operate under the Bankruptcy Cases;
(10) the risks associated with third-party motions in the Bankruptcy Cases;
(11) the potential adverse effects of the Bankruptcy Cases on the Company’s and the other Debtors’ liquidity or results of operations;
(12) the ability to execute the Company’s business plan;
(13) increased legal costs related to the Company’s bankruptcy filing and other litigation;
(14) that the Company’s Class A Common Stock and Class B Common Stock will be, or will continue to be, traded on the OTCQB Marketplace and whether sufficient volumes and liquidity will develop; and
(15) the ability of the Company and the other Debtors to maintain contracts that are critical to their operation, including to obtain and maintain normal terms with their vendors, customers and service providers and to retain key executives, managers and employees.
This discussion is not exhaustive, but is designed to highlight important factors that may impact our forward-looking statements.
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 for the fiscal year ended March 31, 2012, the statements under the heading “Risk Factors” in our Registration Statement on Form S-1 filed with the SEC on July 31, 2012, and the statements included in Article XI — “Certain Risk Factors to be Considered” of the Disclosure Statement, 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 our Annual Report on Form 10-K for the fiscal year ended March 31, 2012, the risk factors under the heading “Risk Factors” in our Registration Statement on Form S-1 filed with the SEC on July 31, 2012, and the risk factors included in Article XI — “Certain Risk Factors to be Considered” of the Disclosure Statement. 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 Current Report on Form 8-K; any forward-looking statement in the Plan or Disclosure Statement is qualified in its entirety as set forth therein. 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. We may further amend, modify or supplement the Plan and the Disclosure Statement, and those amendments, modifications and/or supplements could be material. 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.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 8, 2013
K-V PHARMACEUTICAL COMPANY |
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By: | /s/ Patrick J. Christmas | ||
Patrick J. Christmas | |||
Vice President, General Counsel and Secretary |
Exhibit 99.1
Contact Information:
Ther-Rx:
Brainerd Communicators, Inc.
Tony Herrling
212-739-6738
herrling@braincomm.com
Brad Edwards
212-739-6724
edwards@braincomm.com
Ther-Rx Corporation Announces the Availability of Clindesse® (Clindamycin Phosphate) Vaginal Cream, 2% for Prescribing
Single dose prescription treatment for bacterial vaginosis now available for prescribing
St. Louis, August 5, 2013 – Ther-Rx Corporation, a women's health-focused pharmaceutical company and subsidiary of K-V Pharmaceutical Company (OTCQB Marketplace: KVPHQ/KVPBQ) announced today that Clindesse® (clindamycin phosphate) Vaginal Cream, 2% indicated for the treatment of bacterial vaginosis (BV) in non-pregnant women, is now available for prescribing. Wholesalers have ordered and received product and are distributing to retail pharmacies.
“We are pleased to be able to once again offer Clindesse,” said Greg Divis, CEO of Ther-Rx and K-V. “Together with Gynazole-1®’s reintroduction in January, the availability of Clindesse represents a key positive milestone for the Company as the two products comprising our anti-infectives franchise are both available for prescribing.”
Bacterial vaginosis (BV) is a complex polymicrobial infection that results from an overgrowth of a number of different bacterial species and is the most common vaginal infection in women of childbearing age. Clindesse has been used to treat 2.2 million women and is the first and only single-dose therapy approved for the treatment of BV in non-pregnant women.
Women with BV often self-diagnose and try over-the-counter anti-fungal creams used for yeast infections, which are not effective in treating BV. According to one study published in 2002 of women seeking OTC treatments for self-diagnosed yeast infections, 66% of women had misdiagnosed their condition, which reinforces the importance of being examined by a healthcare provider to diagnose and determine the appropriate treatment.
“Women experiencing vaginal infections are eager for treatments that provide fast relief from symptoms and convenience in dosing and administration,” said Michael Randell, M.D., an Obstetrician and Gynecologist at Northside Hospital in Atlanta, Georgia. “Clindesse and Gynazole-1 are well-established treatment options with high patient satisfaction, so it’s great to be able to prescribe them for my patients again.”
Healthcare providers can find more information at www.clindesse.com and www.gynazole-1.com or by calling Ther-Rx customer service at (877) 567-7676.
Important Safety Information for Clindesse® (clindamycin phosphate) Vaginal Cream, 2%
You should not use Clindesse if you have had an allergic reaction to clindamycin or other drugs in this class (lincosamides). Allergic reactions to other drugs containing clindamycin have included rash, hives, and life-threatening allergic reactions (anaphylaxis). You should not use Clindesse if you have certain bowel diseases, including Crohn’s disease (regional enteritis), ulcerative colitis, or a history of Clostridium difficile-associated diarrhea (CDAD).
CDAD has been reported with nearly all antibiotics, including clindamycin. CDAD may range from mild diarrhea to a fatal inflammation of the colon. Contact your healthcare provider if you experience diarrhea following antibiotic use.
Clindesse contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Due to this, the use of these contraceptives is not recommended during treatment with Clindesse or for 5 days following treatment. During this time period, condoms may not work reliably to prevent pregnancy or to protect against HIV and other sexually transmitted diseases.
Vaginal intercourse or use of other vaginal products is not recommended for at least 7 days following treatment with Clindesse.
The most common side effects of Clindesse are yeast infections, headache, back pain, constipation, and urinary tract infection.
Full prescribing information can be viewed at www.clindesse.com/PDF/PI.pdf.
Important Safety Information for Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%)
You should not use Gynazole-1 if you have had an allergic reaction to butoconazole or other ingredients in this cream.
Gynazole-1 contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Due to this, the use of these contraceptives is not recommended during Gynazole-1 treatment or for 3 days following treatment. During this time period, condoms may not work reliably to prevent pregnancy or to protect against HIV and other sexually transmitted diseases.
The most common side effects of Gynazole-1 are vulvar/vaginal burning, itching, soreness and swelling, and pelvic or abdominal pain or cramping.
Be sure to talk to your doctor if your yeast infection does not get better or you experience frequent yeast infections. Frequent yeast infections, especially those that are difficult to treat, may be caused by another more serious health problem, like a weakened immune system.
Full prescribing information can be viewed at www.gynazole-1.com/PI.PDF.
To report negative side effects, contact Ther-Rx Corporation at 1-877-567-7676 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Ther-Rx Corporation
Ther-Rx Corporation, a subsidiary of 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 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 future 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 the possible outcome of K-V Pharmaceutical Company’s and its affiliated debtors’ (collectively, the “Company”) Chapter 11 proceedings, financing, product launches, governmental and regulatory actions and proceedings, market position, revenues, expenditures and the impact of recalls and suspension of shipments on revenues, adjustments to the financial statements, the filing of amended filings with the Securities and Exchange Commission (the “SEC”) 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 “safe harbor” provisions of the PSLRA, 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) |
the ability of the Company and the other Debtors to continue as a going concern; |
(2) |
the ability of the Company to comply with the milestones in the Stock Purchase and Backstop Agreement, dated June 6, 2013 (as amended, supplemented or modified, the “SPBA”), |
(3) |
the ability of the Company to obtain approval from the United States Bankruptcy Court for the Southern District of New York (the “Bankruptcy Court”) of any motions filed in the Bankruptcy Court; |
(4) |
the ability of the Company to satisfy the conditions of the Company’s proposed chapter 11 plan (as amended, modified or supplemented (the “Plan”)) and to consummate the Plan; |
(5) |
the risks associated with one or more of the counterparties to the SPBA and exit financing commitments failing to consummate the transactions contemplated by such documents; |
(6) |
objections that may be raised with respect to the Plan by the Company’s various creditors, equity holders and other constituents and the Bankruptcy Court’s treatment of such objections; |
(7) |
the effects of the bankruptcy cases on the Company and the interests of various creditors, equity holders and other constituents; |
(8) |
the effects of rulings of the Bankruptcy Court in the bankruptcy cases and the outcome of the cases in general; |
(9) |
the length of time the Company will operate under chapter 11; |
(10) |
risks associated with third-party motions in the bankruptcy cases to the extent that they may interfere with the ability of the Company to consummate the Plan; |
(11) |
the potential adverse effects of the bankruptcy cases on the Company’s liquidity or results of operations; |
(12) |
the ability to execute the Company’s business plans; |
(13) |
increased legal costs related to the Company’s bankruptcy filing and other litigation; |
(14) |
that K-V Pharmaceutical Company Class A Common Stock and Class B Common Stock will be, or will continue to be, traded on the OTCQB Marketplace and whether sufficient volumes and liquidity will develop; and |
(15) |
the ability of the Company to maintain contracts that are critical to its operation, including to obtain and maintain normal terms with their vendors, customers and service providers and to retain key executives, managers and employees. |
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© 2013 Ther-Rx Corporation [20-016]
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