Price Graph
Price
Yield
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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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| Delaware | 83-0221517 | |
| (State or other jurisdiction of | (I.R.S. Employer I.D. No.) | |
| incorporation or organization) | ||
| 2600 Stemmons Frwy, Suite 176, Dallas, TX 75207 | ||
| (Address of principal executive offices) | ||
| (214) 905-5100 | ||
| (Registrant’s telephone number, including area code) | ||
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
þ
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(Do not check if a smaller reporting company)
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||||||
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Page No.
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Item 1 | ||
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●
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MuGard™ is our marketed product for the management of oral mucositis, a frequent side-effect of cancer therapy for which there is no established treatment. The market for mucositis treatment is estimated to be in excess of $2.1 billion world-wide. MuGard, a proprietary nanopolymer formulation, has received marketing allowance in the U.S. from the FDA. We launched MuGard in the U.S. in the fourth quarter of 2010. We are continuing the training of our third-party MuGard representatives on the product, the oral mucositis condition and our sales strategy. MuGard prescriptions are growing quarterly and we have placed emphasis on our sampling and marketing efforts to build demand, grow oncologist awareness and increase payer uptake. Our China partners have received an acceptance letter from the State Food and Drug Administration of the People’s Republic of China which provides marketing approval in China. MuGard has been manufactured in the U.S. and shipped to China for sale. Our China partners anticipate that sales of MuGard will begin in China in the second quarter of 2013. We are actively seeking partners to license MuGard.
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·
●
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Our candidate for the treatment of cancer is ProLindac™, a nanopolymer Diamino Cyclohexane (“DACH”)-platinum prodrug. ProLindac is in Phase 2 of clinical development, and we have completed and evaluated data from several clinical trials with ProLindac. No additional trials have been initiated this year in the U.S. or in Europe as the Company is focusing its resources on growing sales of MuGard. We are working with our partners in China towards the initiation of clinical trials of ProLindac in China. Clinical studies of other indications including liver, colorectal and ovarian cancer are under consideration by Jiangsu Aosaikang Pharmaceutical Co., Ltd, our licensee for ProLindac in China. The DACH-platinum incorporated in ProLindac is the same active moiety as that in oxaliplatin (e.g. Eloxatin; Sanofi-Aventis), which has had annual sales in excess of $2.0 billion. We are currently seeking partners to license this technology.
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●
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CobOral
®
is our proprietary preclinical nanopolymer oral drug delivery technology based on the natural vitamin B12 oral uptake mechanism. We have been developing a product for the oral delivery of insulin, and have conducted sponsored development of a product for oral delivery of a number of peptides and RNAi therapeutics. We are currently seeking partners to license this technology.
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●
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CobaCyte
®
-mediated targeted delivery is a preclinical technology that makes use of the fact that cell surface receptors for vitamins such as B12 are often overexpressed by certain cells including many cancers. This technology uses nanopolymer constructs to deliver more anti-cancer drug to tumors while protecting normal tissues. We are currently seeking partners to license this technology.
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Compound
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Originator
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Technology
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Indication
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Clinical
Stage (1)
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||||
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MuGard™
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Access
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Mucoadhesive
liquid
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Mucositis
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Launched
U.S. and EU
Regulatory
Approval
China
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||||
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ProLindacTM (Polymer
Platinate, AP5346) (2)
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Access /
Univ of
London
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Synthetic
polymer
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Cancer
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Phase 2
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||||
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Oral Insulin
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Access
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Cobalamin
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Diabetes
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Pre-clinical
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||||
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CobOral® Delivery System
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Access
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Cobalamin
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Various
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Pre-clinical
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||||
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CobaCyte®-Targeted Therapeutics
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Access
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Cobalamin
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Anti-tumor
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Pre-clinical
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·
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decreased salary and related costs ($265,000) from reduced scientific staff;
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·
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decreased clinical development with trials for ProLindac and Thiarabine ($99,000);
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·
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decreased stock compensation expense from lower expense of option grants for research and development employees ($32,000); and
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·
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other net decreases in research spending ($31,000).
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·
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decreased salary and related costs ($216,000) from reduced general and administrative staff;
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·
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lower patent fees ($55,000) due to no new patents being filed in 2013;
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·
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decreased director fees ($45,000) due to the fact that 2012 fees were paid in stock because directors had not been paid fees for several years;
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·
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decreased general business consulting expenses due to less use of outside consultants in 2013 ($31,000) versus the same period in 2012;
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·
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decreased net other general and administrative expenses ($73,000); and
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·
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increased MuGard product selling expenses ($95,000).
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·
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Wholesaler and Specialty and Retail Pharmacy Discounts – we offer contractually determined discounts to certain wholesale distributors and specialty and retail pharmacies that purchase directly from us. These discounts are either taken off the invoice at the time of shipment or paid to the customer on a monthly or quarterly basis.
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·
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Prompt Pay Discounts – we offer cash discounts to our customers, generally 2% of the sales price, as an incentive for prompt payment. Based on our experience many of the customers comply with the payment terms to earn the cash discount.
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·
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Patient Discount Programs – we offer discount programs in which patients receive certain discounts off their prescription.
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·
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Managed Care Rebates – we offer discounts under contracts with certain managed care providers who do not purchase directly from us.
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(in thousands)
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Three months ended
March 31, 2013
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Three months ended
March 31, 2012
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||||||
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Gross sales
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$ | 1,255 | $ | 577 | ||||
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Cash discounts
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10 | 5 | ||||||
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Contract discounts
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83 | 18 | ||||||
| $ | 1,162 | $ | 554 | |||||
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
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Exhibits:
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31.1
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Certification of Chief Executive Officer of Access Pharmaceuticals, Inc. filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification of Chief Financial Officer of Access Pharmaceuticals, Inc. filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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32.1*
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Certification of Chief Executive Officer of Access Pharmaceuticals, Inc. filed pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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32.2*
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Certification of Chief Financial Officer of Access Pharmaceuticals, Inc. filed pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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101.INS
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XBRL Instance Document**
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101.SCH
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XBRL Taxonomy Schema**
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101.CAL
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XBRL Taxonomy Calculation Linkbase Document**
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101.DEF
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XBRL Taxonomy Definition Linkbase Document**
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101.LAB
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XBRL Taxonomy Label Linkbase Document**
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101.PRE
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XBRL Taxonomy Presentation Linkbase Document**
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Date:
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May 15, 2013 |
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By:
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/s/ Jeffrey B. Davis |
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Jeffrey B. Davis
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|||||
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Chief Executive Officer
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|||||
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(Principal Executive Officer)
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|||||
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Date:
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May 15, 2013 |
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By:
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/s/ Stephen B. Thompson |
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Stephen B. Thompson
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Vice President and Chief Financial Officer
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(Principal Financial and Accounting Officer)
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March 31, 2013
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December 31, 2012
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|||
| ASSETS | (unaudited) | ||||
| Current assets | |||||
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Cash and cash equivalents
Receivables
Inventory
Prepaid expenses and other current assets
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$ 50,000
1,231,000
150,000
242,000
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$ 396,000
840,000
194,000
251,000
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|||
| Total current assets | 1,673,000 | 1,681,000 | |||
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Property and equipment, net
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6,000
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7,000
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|||
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Other assets
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42,000
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42,000
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|||
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Total assets
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$
1,721,000
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$
1,730,000
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|||
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LIABILITIES AND STOCKHOLDERS' DEFICIT
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|||||
| Current liabilities | |||||
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Accounts payable
Accrued expenses
Dividends payable
Current portion of deferred revenue
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$ 2,385,000
857,000
4,256,000
247,000
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$ 2,039,000
857,000
3,486,000
247,000
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|||
| Total current liabilities | 7,745,000 | 6,629,000 | |||
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Derivative liability - warrants
Derivative liability - preferred stock
Long-term deferred revenue
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518,000
4,420,000
2,644,000
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271,000
9,200,000
2,706,000
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|||
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Total liabilities
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15,327,000
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18,806,000
|
|||
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Commitments and contingencies
|
|||||
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Stockholders' deficit
Convertible preferred stock Series A - $.01 par value; authorized
2,000,000 shares; 2,913.3617 shares issued at March 31,
2013 and 2,913.3617 shares issued at December 31, 2012
Convertible preferred stock Series B - $.01 par value; authorized
2,000,000 shares; 1,000.0 shares issued at March 31,
2013 and 1,000.0 shares issued at December 31, 2012
Common stock - $.01 par value; authorized 100,000,000 shares;
issued, 24,833,855 at March 31, 2013 and 24,732,312 at
December 31, 2012
Additional paid-in capital
Treasury stock, at cost – 163 shares
Accumulated deficit
|
-
-
248,000
250,768,000
(4,000)
(264,618,000
)
|
-
-
247,000
250,653,000
(4,000)
(267,972,000
)
|
|||
| Total stockholders' deficit |
(13,606,000)
|
(17,076,000)
|
|||
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Total liabilities and stockholders' deficit
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$
1,721,000
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$
1,730,000
|
|||
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Three Months ended March 31,
|
||||||||
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2013
|
2012
|
|||||||
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Revenues
|
||||||||
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Product sales
|
$ | 1,162,000 | $ | 554,000 | ||||
|
License revenues
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62,000 | 1,262,000 | ||||||
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Royalties
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- | 21,000 | ||||||
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Total revenues
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1,224,000 | 1,837,000 | ||||||
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Expenses
|
||||||||
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Research and development
|
323,000 | 750,000 | ||||||
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Product costs
|
65,000 | 59,000 | ||||||
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Selling, general and administrative
|
1,338,000 | 1,663,000 | ||||||
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Depreciation and amortization
|
1,000 | 54,000 | ||||||
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Total expenses
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1,727,000 | 2,526,000 | ||||||
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Loss from operations
|
(503,000 | ) | (689,000 | ) | ||||
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Interest and miscellaneous income
|
94,000 | 1,000 | ||||||
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Interest and other expense
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(43,000 | ) | (169,000 | ) | ||||
| Warrant extension expense | - | (2,316,000 | ) | |||||
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(Loss) gain on change in fair value of derivative – warrants
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(247,000 | ) | 741,000 | |||||
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Gain (loss) on change in fair value of derivative –
preferred stock
|
4,780,000 | (2,460,000 | ) | |||||
| 4,584,000 | (4,203,000 | ) | ||||||
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Net income (loss)
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4,081,000 | (4,892,000 | ) | |||||
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Less preferred stock dividends
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727,000 | 440,000 | ||||||
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Net income (loss) allocable to common stockholders
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$ | 3,354,000 | $ | (5,332,000 | ) | |||
| Net income (loss) per common share | ||||||||
|
Basic
|
$ | 0.14 | $ | (0.22 | ) | |||
| Diluted | $ | 0.13 | $ | (0.22 | ) | |||
| Weighted average number of common shares outstanding | ||||||||
|
Basic
|
24,800,936 | 24,145,488 | ||||||
|
Diluted
|
25,156,201 | 24,145,488 | ||||||
|
Common Stock
|
Preferred Stock – A
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Preferred Stock – B
|
||||||||||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional
paid-in
capital
|
Treasury
stock
|
Accumulated
deficit
|
||||||||||||||||||||||||||||
|
Balance
December 31, 2012
|
24,732,312 | $ | 247,000 | 2,913.3617 | $ | - | 1,000.0 | $ | - | $ | 250,653,000 | $ | (4,000 | ) | $ | (267,972,000 | ) | |||||||||||||||||||
|
Common stock
issued for services
|
28,043 | - | - | - | - | - | 10,000 | - | - | |||||||||||||||||||||||||||
|
Common stock
issued to employees
|
73,500 | 1,000 | - | - | - | - | 28,000 | - | - | |||||||||||||||||||||||||||
|
Stock option comp-
ensation expense
|
- | - | - | - | - | - | 77,000 | - | - | |||||||||||||||||||||||||||
|
Preferred dividends
|
- | - | - | - | - | - | - | - | (727,000 | ) | ||||||||||||||||||||||||||
|
Net income
|
- | - | - | - | - | - | - | - | 4,081,000 | |||||||||||||||||||||||||||
|
Balance
March 31, 2013
|
24,833,855 | $ | 248,000 | 2,913.3617 | $ | - | 1,000.0 | $ | - | $ | 250,768,000 | $ | (4,000 | ) | $ | (264,618,000 | ) | |||||||||||||||||||
|
Three Months ended March 31,
|
||||||||
|
2013
|
2012
|
|||||||
|
Cash flows from operating activities:
|
||||||||
|
Net income (loss)
|
$ | 4,081,000 | $ | (4,892,000 | ) | |||
|
Adjustments to reconcile net loss to cash used
in operating activities:
|
||||||||
|
Gain (loss) on change in fair value of derivative - warrants
|
247,000 | (741,000 | ) | |||||
|
Gain (loss) on change in fair value of derivative –
preferred stock
|
(4,780,000 |
)
|
2,460,000 | |||||
| Warrant extension expense | 2,316,000 | |||||||
|
Depreciation and amortization
|
1,000 | 54,000 | ||||||
|
Stock option compensation expense
Stock issued to directors and employees
|
77,000 29,000 | 114,000 302,000 | ||||||
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Stock issued for services
|
10,000 | 30,000 | ||||||
|
Change in operating assets and liabilities:
|
||||||||
|
Receivables
|
(391,000 | ) | (601,000 | ) | ||||
|
Inventory
|
44,000 | 54,000 | ||||||
|
Prepaid expenses and other current assets
|
9,000 | (4,000 | ) | |||||
|
Other assets
|
- | 4,000 | ||||||
|
Accounts payable and accrued expenses
|
346,000 | 165,000 | ||||||
|
Interest payable on dividends
|
43,000 | 86,000 | ||||||
|
Accrued interest payable
|
- | 83,000 | ||||||
|
Deferred revenue
|
(62,000 | ) | (512,000 | ) | ||||
|
Net cash used in operating activities
|
(346,000 | ) | (1,082,000 | ) | ||||
|
Cash flows from investing activities:
|
||||||||
|
Capital expenditures
|
- | (13,000 | ) | |||||
|
Net cash used in investing activities
|
- | (13,000 | ) | |||||
|
Net increase (decrease) in cash and cash equivalents
|
(346,000 | ) | (1,095,000 | ) | ||||
|
Cash and cash equivalents at beginning of period
|
396,000 | 2,460,000 | ||||||
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Cash and cash equivalents at end of period
|
$ | 50,000 | $ | 1,365,000 | ||||
|
Supplemental cash flow information:
|
||||||||
|
Cash paid for interest
|
$ | - | $ | - | ||||
|
Supplemental disclosure of noncash transactions:
|
||||||||
|
Shares issued for dividends on preferred stock
|
- | 13,000 | ||||||
|
Preferred stock dividends in dividends payable
|
$ | 727,000 | $ | 440,000 | ||||
| (1) | Interim Financial Statements |
| (2) | Liquidity |
| (3) | Fair Value of Financial Instruments |
|
·
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Level 1 – Quoted prices in active markets for identical assets or liabilities.
|
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·
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Level 2 – Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
|
|
·
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Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.
|
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(in thousands)
|
||||||||||||||||||||
|
Description
|
As of
March 31, 2013
|
Level 1
|
Level 2
|
Level 3
|
Total Gains
(Losses)
|
|||||||||||||||
|
Liabilities:
Derivative liability-
|
||||||||||||||||||||
|
warrants
|
$ | 518 | $ | - | $ | 518 | $ | - | $ | (247 | ) | |||||||||
|
preferred stock
|
$ | 4 , 420 | $ | - | $ | - | $ | 4 , 420 | $ | 4 , 780 | ||||||||||
|
(in thousands)
|
||||||||||||||||||||
|
Description
|
As of
December 31, 2012
|
Level 1
|
Level 2
|
Level 3
|
Total Gains
(Losses)
|
|||||||||||||||
|
Liabilities:
Derivative liability-
|
||||||||||||||||||||
|
warrants
|
$ | 271 | $ | - | $ | 271 | $ | - | $ | 1 , 236 | ||||||||||
|
preferred stock
|
$ | 9 , 200 | $ | - | $ | - | $ | 9,200 | $ | (4 , 770 | ) | |||||||||
| (4) | Stock Based Compensation |
|
Three months ended
March 31
,
|
||||||||
|
2013
|
2012
|
|||||||
|
Research and development
|
$ | 9,000 | $ | 42 ,000 | ||||
|
Selling, general and administrative
|
68 ,000 | 72 ,000 | ||||||
|
Stock-based compensation expense
included in operating expense
|
$ | 77 ,000 | $ | 114 ,000 | ||||
| (5) | Litigation |
| (6) | Basic and Diluted Net Income (Loss) Per Common Share |
|
(in thousands, except share and per share amounts)
|
Three months ended
March 31,
|
|||||||
|
2013
|
2012
|
|||||||
|
Net income (loss)
|
$ | 3,354 | $ | (5,332 | ) | |||
|
Weighted average shares outstanding
|
24,800,936 | 24,145,488 | ||||||
|
Basic net income (loss) per common share
|
$ | 0.14 | $ | (0.22 | ) | |||
|
Net income (loss)
|
$ | 3,354 | $ | (5,332 | ) | |||
|
Weighted average shares outstanding
|
24,800,936 | 24,145,488 | ||||||
|
Effect of dilutive options and warrants
|
355,265 | - | ||||||
|
Weighted average shares outstanding assuming dilution
|
25,156,201 | 24,145,488 | ||||||
|
Diluted net income (loss) per common share
|
$ | 0.13 | $ | (0.22 | ) | |||
|
March 31, 2013
|
||||
|
Warrants
|
35,683,943 | |||
|
Stock options
|
863,904 | |||
|
Preferred stock Series A
|
58,267,234 | |||
|
Preferred stock Series B
|
20,000,000 | |||
|
Total
|
114,815,081 | |||
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|