Targeted
Medical Pharma, Inc. (OTCQB: TRGM), a biotechnology company that
develops and distributes prescription medical foods, convenience kits
and generic pharmaceuticals to physicians and pharmacies, today filed
its 10-K and announced the Company’s 2012 financial results.
“We are pleased to report that the second half of 2012 has come back
strong and clearly reflects the traction we are seeing as we continue to
gain momentum,” said Chief Executive and Chief Scientific Officer
William Shell, M.D. “Revenue decreased in the first half of 2012
primarily due to concerns among physicians regarding the changes in
legislation that could have impacted payments to physicians who dispense
pharmaceuticals. Fortunately, the final bill did not impact the sale of
medical foods or medical food convenience kits. When physicians
understood this in the second half of 2012, the Company saw an
acceleration of growth.”
Dr. Shell continued, “A second bill passed accelerating payment of old
workers compensation claims. As our Company recognized revenue for
workers compensation claims only upon collection, this benefits our
Company twofold – both through improved cash flow and increased revenue.
In July, the acceleration of both dispenses and collections of workers
compensation claims were seen due to the legislation that ultimately
passed. Another consequence of this legislation has been the near
elimination of the compounded pain medication marketplace. The impact on
the compounded medication marketplace, which is a competitor for medical
foods in some cases, has also positively increased medical food
dispensing and revenue, particularly the Company’s product TheramineTM.
The Company continues to show a narrowing of its net operating loss and
improvement of its EBIDTA based on the preliminary unaudited analysis of
its 2013 first quarter performance.”
As of December 31, 2012 the Company had a $34.4 million off balance
sheet asset due to unrecorded accounts receivable for delivered
products. This unrecognized off balance sheet asset has the potential to
be recorded as revenue in the future as the Company’s CCPI subsidiary
collects receivables on behalf of the Company’s Physician Managed
business model and Hybrid business model customers’ claims.
Dr. Shell, M.D. continued, “Our strategic focus over the past year has
been to expand distribution channels and enhance reimbursement mix,
increase cash collections, and further develop our pipeline of
proprietary prescription-only medical foods. I am pleased to report that
we have made solid progress against each of these initiatives, as the
Company transitions from development stage into a growing business with
excellent long-term potential.
“On the corporate front, we welcomed Kerry Weems to our board of
directors. Mr. Weems is a nationally respected expert in health policy
and government finance, who most recently was Acting Administrator of
the Centers for Medicare and Medicaid Services (CMS) and Vice-Chairman
of the American Health Information Community,” said Dr. Shell. “We also
announced the appointment of Fred McCall-Perez, Ph.D. as our new
director of medical affairs.”
Key 2012 and Recent Achievements
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On March 4, 2013 the Company unveiled new results from an open label
study of its oral amino acid-based erythrocyte stimulating system
(ESS) for the treatment of chronic anemia. The Company’s ESS system is
designed to stimulate progenitor stem cells in the bone marrow.
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Awarded a patent on February 5, 2013 from the United States Patent and
Trademark Office relating to a system and method for electronically
submitting medication claims by point-of-care physicians. This is the
seventh patent issued to the Company.
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In December of 2012, five of the Company’s core prescription-only
medical foods were added to the U.S. Department of Veterans Affairs
Federal Supply Schedule.
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Entered into an agreement with Cambridge Medical Funding Group,
allowing physicians to assign California Workers’ Compensation
receivables to Cambridge, providing revenue to the Company and
physicians within seven to ten days of assignment for all products
dispensed and billed for participating doctors.
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Reported data from an open-label pilot study indicating that Target
Medical Pharma’s new amino acid-based oral product Percura™ reduced
symptoms of pain and numbness related to peripheral neuropathy. This
product is designed to orally stimulate progenitor neuronal stem
cells, promoting their growth.
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Reported data indicating that Targeted Medical Pharma’s new amino acid
oral formulation stimulated mature red blood cell and reticulocyte
development. The study group included patients with chronic anemia.
This product is designed to orally stimulate genesis of bone marrow
progenitor stem cells. The company submitted four new patent
applications related to the oral stimulation of progenitor stem cells.
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Confirmed a relationship between autonomic nervous system dysfunction
and Gulf War Illness. This is the first study to establish a medical
basis for symptoms of Gulf War Illness in a large, representative
sample of veterans using validated medical tests.
Published Scientific Papers
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Analyzing pharmacoeconomics of Targeted Medical Pharma’s drug,
Theramine™, versus non-steroidal anti-inflammatory drugs, showing a
significant cost saving for patients taking Theramine compared to
NSAIDs when accounting for the cost of the side effects of NSAIDs.
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Demonstrating that Sentra PM™ improved sleep latency and improved
nighttime parasympathetic nervous system activity as a standalone
medication or used in conjunction with a low dose of Trazadone, based
on results from a clinical trial of the Company’s proprietary medical
food product, Sentra PM™.
Accepted to Present Clinical Posters
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Accepted to present “Theramine versus ibuprofen for the safe and
effective management of chronic low back pain and inflammation,” at
PAINWeek 2012, held in Las Vegas, Nevada, and at the 118th
Annual Meeting of AMSUS in Phoenix 2012.
2013 Corporate Objectives
The Company provided the following key strategic goals for 2013:
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Expanding its presence in the Workers’ Compensation marketplace,
beginning with California and then nationally;
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Further increasing penetration in the private insurance market, as
well as into Medicare and Medicaid populations; and accelerating its
sales and marketing efforts.
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Continue developing its product pipeline. The Company’s treatments for
neuropathy, chronic anemia, asthma, nasal congestion and diabetes are
currently undergoing clinical studies.
“We are dedicated to bringing our prescription medications to patients
who have long sought alternatives to more dangerous prescription drugs,”
said David S. Silver, M.D., Targeted Medical Pharma’s President and
Chief Operating Officer. “Increasing recognition of medical foods as a
class within the U.S. Food & Drug Administration, along with heightened
awareness among the medical community and patients, positions us for
commercial success. Ensuring broad patient access and building our brand
presence represent key objectives, as we move forward in the current
year.”
Detailed financial data information is available on Targeted Medical
Pharma’s annual report (Form 10-K), which is accessible on the Company’s
website and on this
page of the SEC’s website.
About Targeted Medical Pharma, Inc.
Targeted Medical Pharma is a Los Angeles-based biotechnology company
that develops prescription medical
foods for the treatment of chronic disease, including pain
syndromes, peripheral neuropathy, hypertension, obesity, sleep and
cognitive disorders. The company manufactures 10 proprietary
prescription-only medical foods, as well as 48 convenience packed kits,
which pair a medical food and branded or generic pharmaceutical. These
prescription medical foods and therapeutic systems are sold to
physicians and pharmacies in the U.S. and the Middle East through the
company’s subsidiary, Physician
Therapeutics. These proprietary medications represent a novel
approach to the management of certain disease states, focusing on safety
and efficacy without the deleterious side effects of traditional, high
dose prescription drugs. The company is developing nutrient-based
systems for oral stimulation of progenitor stem cells that differentiate
into neurons, red blood cells, pituitary hormones including IGF-I.
Targeted Medical Pharma also provides a billing and collection services
on behalf of dispensing physicians.
Forward Looking Statement
This press release may contain forward-looking statements
related to the company’s business strategy, outlook, objectives, plans,
intentions or goals. The words "may," "will," "should," "plans,"
"explores," "expects," "anticipates," "continue," "estimate," "project,"
"intend," and similar expressions, identify forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995, but their absence does not mean that the statement is not
forward-looking. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties, and
assumptions that are difficult to predict. Actual results could differ
materially. Targeted Medical Pharma expressly disclaim any obligation or
undertaking to update or revise any forward-looking statement contained
herein to reflect any change in the company's expectations with regard
thereto or any change in events, conditions or circumstances upon which
any statement is based.