PALATIN TECHNOLOGIES INC - Annual Report: 2015 (Form 10-K)

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[X]	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

 

[  ]	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

 

 

Delaware		95-4078884
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
4B Cedar Brook Drive Cranbury, New Jersey		08512
(Address of principal executive offices)		(Zip Code)

 

 

 

 

Title of Each Class		Name of Each Exchange on Which Registered
Common Stock, par value $.01 per share		NYSE MKT

 

 

 

 

 

 

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		Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	18
Item 1B.	Unresolved Staff Comments	37
Item 2.	Properties	37
Item 3.	Legal Proceedings	37
Item 4.	Mine Safety Disclosures	37
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	38
Item 6.	Selected Financial Data	38
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	39
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	43
Item 8.	Financial Statements and Supplementary Data	44
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	65
Item 9A.	Controls and Procedures	65
Item 9B.	Other Information	65
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	66
Item 11.	Executive Compensation	70
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	76
Item 13.	Certain Relationships and Related Transactions, and Director Independence	80
Item 14.	Principal Accountant Fees and Services	81
PART IV
Item 15.	Exhibits, Financial Statement Schedules	82

 

 

 

 

 

 

 

 

 

 

●

Bremelanotide, an on-demand subcutaneous injectable peptide melanocortin receptor agonist, for treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual response. Bremelanotide is in Phase 3 clinical trials, with patient enrollment projected to be completed this year, and topline results in the third quarter of calendar 2016;

 

●

Melanocortin receptor-4, or MC4r, compounds for treatment of obesity and diabetes. Results of our studies involving MC4r peptides suggest that certain of these peptides may have significant commercial potential for treatment of conditions responsive to MC4r activation, including FSD, erectile dysfunction or ED, obesity and diabetes;

 

●

PL-3994, a natriuretic peptide receptor-A, or NPR-A, agonist, for treatment of cardiovascular and pulmonary indications. PL-3994 is our lead natriuretic peptide receptor product candidate, and is a synthetic mimetic of the neuropeptide hormone atrial natriuretic peptide, or ANP. PL-3994 is in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension; and

 

●

Melanocortin receptor-1, or MC1r, agonist peptides for treatment of inflammatory and dermatologic disease indications. Our MC1r peptide drug candidates are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. We have selected one of our MC1r peptide drug candidates, designated PL-8177, as a clinical trial candidate.

 

 

 

 

 

 

●	Using our technology and expertise to develop and commercialize products in our active drug development programs;

 

●	Entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that we are developing;

 

●	Partially funding our product development programs with the cash flow generated from research collaboration and license agreements and any potential future agreements with third parties; and

 

●	Completing development and seeking regulatory approval of bremelanotide for FSD and our other product candidates.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	completion of preclinical laboratory tests, preclinical animal testing and formulation studies;

 

●	submission to the FDA of an IND, which must be in effect before clinical trials may commence;

 

●	submission to the FDA of an NDA that includes preclinical data, clinical trial data and manufacturing information;

 

●	payment of substantial user fees for filing the NDA and other recurring user fees;

 

●	FDA review of the NDA;

 

●	satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities; and

 

●	FDA approval of the NDA, including approval of all product labeling.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	recordkeeping requirements;

 

●	periodic reporting requirements;

 

●	GMP requirements related to all stages of manufacturing, testing, storage, packaging, labeling and distribution of finished dosage forms of the product;

 

●	monitoring and reporting of adverse experiences with the product; and

 

●	advertising and promotional reporting requirements and restrictions.

 

 

 

 

●	restrictions on the marketing or manufacturing of a product;

 

●	Warning Letters or Untitled Letters from the FDA asking us, our collaborators or third-party contractors to take or refrain from taking certain actions;

 

●	withdrawal of the product from the market;

 

●	the FDA’s refusal to approve pending applications or supplements to approved applications;

 

●	voluntary or mandatory product recall;

 

●	fines or disgorgement of profits or revenue;

 

●	suspension or withdrawal of regulatory approvals;

 

●	refusals to permit the import or export of products;

 

●	product seizure; and

 

●	injunctions or the imposition of civil or criminal penalties.

 

 

 

●

the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs;

 

●

federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

 

●

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

 

●

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

 

●

the federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; and

 

●

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	continuing to conduct preclinical development and clinical trials;

 

●	participating in regulatory approval processes;

 

●	formulating and manufacturing products, or having third parties formulate and manufacture products;

 

●	post-approval monitoring and surveillance of our products;

 

●	conducting sales and marketing activities, either alone or with a partner; and

 

●	obtaining additional capital.

 

 

 

●	the ability to raise additional capital on acceptable terms, or at all;

 

●	timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

 

●	whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;

 

●	acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities;

 

●	our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product candidates or any future product candidates;

 

●	the prevalence, duration and severity of potential side effects experienced with our product candidates or future approved products, if any;

 

 

●	the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

●	achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any;

 

●

the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with GMP;

 

●	a continued acceptable safety profile and efficacy during clinical development and following approval of our product candidates or any future product candidates;

 

●	our ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others;

 

●	acceptance by physicians and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments;

 

●	our and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates;

 

●	our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and

 

●	our ability to in-license or acquire additional product candidates or commercial-stage products that we believe can be successfully developed and commercialized.

 

 

 

 

 

 

 

 

 

●	the results of our Phase 3 clinical trials for bremelanotide for FSD;

 

●	the timing of, and the costs involved in, obtaining regulatory approvals for bremelanotide for FSD and our other product candidates;

 

●	the number and characteristics of any additional product candidates we develop or acquire;

 

●	the scope, progress, results and costs of researching and developing bremelanotide for FSD, PL-3994 or any future product candidates, and conducting preclinical and clinical trials;

 

●	the cost of commercialization activities if bremelanotide for FSD, PL-3994 or any future product candidates are approved for sale, including marketing, sales and distribution costs;

 

●	the cost of manufacturing bremelanotide for FSD, PL-3994 or any future product candidates and any products we successfully commercialize and maintaining our related facilities;

 

●	our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms and timing of such arrangements;

 

●	the degree and rate of market acceptance of any future approved products;

 

●	the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;

 

●	any product liability or other lawsuits related to our products;

 

●	the expenses needed to attract and retain skilled personnel;

 

●	the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and

 

●	the timing, receipt and amount of sales of, or royalties on, future approved products, if any.

 

 

 

 

 

 

●

timely completion of, or need to conduct additional, clinical trials, including our Phase 3 clinical trials in the United States for bremelanotide for FSD, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the accurate and satisfactory performance of third-party contractors;

 

●	our ability to demonstrate to the satisfaction of the FDA the safety and efficacy of bremelanotide for FSD or any future product candidates through clinical trials;

 

●	whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of bremelanotide for FSD or any future product candidates;

 

●	the acceptance of parameters for regulatory approval, including our proposed indication, primary endpoint assessment and primary endpoint measurement, relating to our lead indications of bremelanotide for FSD;

 

 

●	our success in educating physicians and patients about the benefits, administration and use of bremelanotide for FSD or any future product candidates, if approved;

 

●	the prevalence and severity of adverse events experienced with bremelanotide for FSD or any future product candidates or approved products;

 

●	the adequacy and regulatory compliance of the autoinjector device, supplied by an unaffiliated third party, to be used as part of our bremelanotide combination product;

 

●	the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

 

●	our ability to raise additional capital on acceptable terms to achieve our goals;

 

●	achieving and maintaining compliance with all regulatory requirements applicable to bremelanotide for FSD or any future product candidates or approved products;

 

●	the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;

 

●	the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations;

 

●	our ability to manufacture clinical trial supplies of bremelanotide for FSD or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current GMP;

 

●	our ability to successfully commercialize bremelanotide for FSD or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;

 

●	our ability to enforce our intellectual property rights in and to bremelanotide for FSD or any future product candidates;

 

●	our ability to avoid third-party patent interference or intellectual property infringement claims;

 

●	acceptance of bremelanotide for FSD or any future product candidates, if approved, as safe and effective by patients and the medical community; and

 

●	a continued acceptable safety profile and efficacy of bremelanotide for FSD or any future product candidates following approval.

 

 

 

 

●	lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints;

 

●	failure to design appropriate clinical trial protocols;

 

●	uncertainty regarding proper dosing;

 

●	inability to develop or obtain a supplier for an autoinjector device that meets the FDA’s medical device requirements;

 

●	insufficient data to support regulatory approval;

 

 

●	inability or unwillingness of medical investigators to follow our clinical protocols;

 

●	inability to add a sufficient number of clinical trial sites; or

 

●	the availability of sufficient capital to sustain operations and clinical trials.

 

 

●	product approval or clearance;

 

●	regulatory compliance;

 

●	good manufacturing practices;

 

●	intellectual property rights;

 

●	product introduction; and

 

●	marketing and competition.

 

 

 

●	discovery of serious or unexpected toxicities or side effects experienced by study participants or other safety issues;

 

●

slower than expected rates of subject recruitment and enrollment rates in clinical trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment;

 

●	difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

 

●	difficulty in obtaining institutional review board, or IRB, approval for studies to be conducted at each site;

 

●	delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;

 

●	inadequacy of or changes in our manufacturing process or the product formulation or method of delivery;

 

●	changes in applicable laws, regulations and regulatory policies;

 

●	delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research organizations, or CROs, clinical trial sites and other third-party contractors;

 

●	failure of our CROs or other third-party contractors to comply with contractual and regulatory requirements or to perform their services in a timely or acceptable manner;

 

●

failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug, medical device and biologic products;

 

●	delays in the scheduling and performance by the FDA of required inspections of us, our CROs, our suppliers, or our clinical trial sites, and violations of law or regulations by discovered in the course of FDA inspections;

 

●	scheduling conflicts with participating clinicians and clinical institutions; or

 

●	difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data.

 

 

 

 

 

 

 

●	perceptions by members of the healthcare community, including physicians, about its safety and effectiveness;

 

●	cost-effectiveness relative to competing products and technologies;

 

●	availability of reimbursement for our products from third-party payers such as health insurers, health maintenance organizations and government programs such as Medicare and Medicaid; and

 

●	advantages over alternative treatment methods.

 

 

 

 

 

 

●	regulatory authorities may withdraw their approval of the product;

 

●	we may be required to reformulate such products or change the way the product is manufactured;

 

 

●	we may become the target of lawsuits, including class action suits; and

 

●	our reputation in the market place may suffer resulting in a significant drop in the sales of such products.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	reliance on the third party for regulatory compliance and quality assurance;

●	the possible breach of the manufacturing agreement by the third party because of factors beyond our control;

●	the possible termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us; and

●	drug product supplies not meeting the requisite requirements for clinical trial use.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●

the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs;

 

●

the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients to providers of “designated health services” with whom the physician or a member of the physician’s immediate family has an ownership interest or compensation arrangement, unless a statutory or regulatory exception applies;

 

●

federal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us to the extent that our interactions with customers may affect their billing or coding practices; and

 

●	state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers.

 

 

 

 

 

 

 

 

 

 

 

 

 

●	restrictions on the products or manufacturing process;

 

●	warning letters;

 

●	civil or criminal penalties;

 

●

fines;

 

●	injunctions;

 

●	imposition of a Corporate Integrity Agreement requiring heightened monitoring of our compliance functions, overseen by outside monitors, and enhanced reporting requirements to, and oversight by, the FDA and other government agencies;

 

●	product seizures or detentions and related publicity requirements;

 

●	suspension or withdrawal of regulatory approvals;

 

●	regulators or IRBs may not authorize us or any potential future collaborators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

 

●	total or partial suspension of production; and

 

●	refusal to approve pending applications for marketing approval of new product candidates.

 

 

 

 

 

 

 

 

 

 

●	completion of non-clinical tests including preclinical laboratory and formulation studies and animal testing and toxicology;

 

●	submission to the FDA of an Investigational New Drug, or IND, application, which must become effective before clinical trials may begin, and which may be placed on “clinical hold” by the FDA, meaning the trial may not commence, or must be suspended or terminated prior to completion;

 

●

performance of adequate and well-controlled Phase 1, 2 and 3 human clinical trials to establish the safety and efficacy of the drug for each proposed indication, and potentially post-approval or Phase 4 studies to further define the drug’s efficacy and safety, generally or in specific patient populations;

 

●	submission to the FDA of a New Drug Application, or NDA, that must be accompanied by a substantial “user fee” payment;

 

●	FDA review and approval of the NDA before any commercial marketing or sale; and

 

●	compliance with post-approval commitments and requirements.

 

 

 

 

 

 

 

 

 

●	require changes to manufacturing methods;

 

 

●	require recall, replacement or discontinuance of one or more of our products;

 

●	require additional recordkeeping;

 

●	limit or restrict our ability to engage in certain types of marketing or promotional activities;

 

●	alter or eliminate the scope or terms of any currently available regulatory exclusivities; and

 

●	restrict or eliminate our ability to settle any patent litigation we may bring against potential generic competitors.

 

 

 

 

 

 

 

 

 

●	the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;

 

●	if and when patents will be issued;

 

●	whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; and

 

●	whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose.

 

 

 

●	obtain licenses, which may not be available on commercially reasonable terms, if at all;

 

●	redesign our products or processes to avoid infringement;

 

●	stop using the subject matter claimed in the patents held by others;

 

●	pay damages; or

 

●	defend litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion of our management resources.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	publicity regarding actual or potential clinical results relating to products under development by our competitors or us;

 

●	delay or failure in initiating, completing or analyzing preclinical or clinical trials or unsatisfactory designs or results of these trials;

 

●	interim decisions by regulatory agencies, including the FDA, as to clinical trial designs, acceptable safety profiles and the benefit/risk ratio of products under development;

 

●	achievement or rejection of regulatory approvals by our competitors or by us;

 

●	announcements of technological innovations or new commercial products by our competitors or by us;

 

●	developments concerning proprietary rights, including patents;

 

●	developments concerning our collaborations;

 

●	regulatory developments in the United States and foreign countries;

 

●	economic or other crises and other external factors;

 

●	period-to-period fluctuations in our revenue and other results of operations;

 

●	changes in financial estimates by securities analysts; and

 

●	sales of our common stock (or the perception that such sales could occur).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	60,592 shares issuable on the conversion of immediately convertible Series A Convertible preferred stock, subject to adjustment, for no further consideration;

●	5,077,290 shares issuable on the exercise of stock options, at exercise prices ranging from $0.60 to $24.90 per share;

●	1,028,017 shares issuable under restricted stock units which vest on dates between June 11, 2016 and June 11, 2019, subject to the fulfillment of service conditions; and

●	115,061,618 shares issuable on the exercise of warrants at exercise prices ranging from $0.01 to $1.00 per share.

 

 

 

 

●	a limited availability of market quotations for our securities;

●	reduced liquidity with respect to our securities;

●	a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock;

●	a limited amount of news and analyst coverage for our company; and

●	a decreased ability to issue additional securities or obtain additional financing in the future.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FISCAL YEAR ENDED JUNE 30, 2015		HIGH				LOW
Fourth Quarter		$	1.58			$	0.85
Third Quarter			1.34				0.65
Second Quarter			0.93				0.59
First Quarter			1.28				0.82
FISCAL YEAR ENDED JUNE 30, 2014		HIGH				LOW
Fourth Quarter		$	1.43			$	0.97
Third Quarter			1.50				0.73
Second Quarter			0.83				0.56
First Quarter			0.76				0.59

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

●	the development and testing of products in animals and humans;

 

●	product approval or clearance;

 

●	regulatory compliance;

 

●	GMP compliance;

 

●	intellectual property rights;

 

●	product introduction;

 

●	marketing, sales and competition; and

 

●	obtaining sufficient capital.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

	Page
Report of Independent Registered Public Accounting Firm	45
Consolidated Balance Sheets	46
Consolidated Statements of Operations	47
Consolidated Statements of Stockholders’ Equity	48
Consolidated Statements of Cash Flows	49
Notes to Consolidated Financial Statements	50