http://www.businessweek.com/articles/2014-04-17/retrophins-martin-shkreli-the-biotech-short-seller-who-went-long
I do not think he is serious about buying Clinuvel. He wants the publicity for "trying" to buy Clinuvel. He does not even have the money per his last SEC filing. He is willing to offer shares in his company as a trade. Now why would any of us change our Clinuvel shares for his shares in Retrophin. (per most recent filling, only 444 individuals hold Retrophil, it just came off the Over the Counter and got Nasdaq to list it) If he really wanted to buy Clinuvel, from a legal standpoint or business standpoint he is going about it fecklessly and impulsively careless. If he was smart enough to reach his goal of actually acquiring Clinuvel, then he is not very smart in understanding how to go about it. Therefor he is not very smart and does not do homework well, then his goal is not actually to acquire Clinuvel. He must be smart in some other goal ? but not actually buying Clinuvel.
"Transcept Pharmaceuticals Inc. rejected an unsolicited offer from Martin Shkreli's Retrophin Inc., the drug developer said Wednesday, as it licensed a migraine drug from a Japanese company.
Richmond-based Transcept (NASDAQ: TSPT) said in a press release that the $4-per-share offer is "not in the best interests of Transcept or its shareholders." It marks the second rebuff of the company founded by Shkreli, a 30-year-old health care hedge fund manager and activist shareholder.
Transcept, which developed the middle-of-the-night sleep drug Intermezzo, earlier this month rejected a Retrophin offer of $3.50 per share.
Intermezzo, which won Food and Drug Administration approval in November 2011, is controlled by Purdue Pharma, which pays royalties to Transcept, but it has had trouble breaking into a sleep drug market dominated by all-night sleeping pills like Ambien.
Purdue no longer is actively marketing Intermezzo.
Roumell Asset Management, Transcept's largest shareholder, last week said Retrophin's $4 offer was "woefully inadequate" because it offers basically little more than the cash value of the company. It estimated that getting rights to Intermezzo back from Purdue could put Transcept's price at closer to $7 per share.
"If Transcept is unable to repossess Intermezzo on its own, we believe there are companies willing to put their efforts toward that end and will pay for that optionality," President James Roumell said in a letter to Transcept's board.
Not that Roumell is totally behind Transcept management. He claimed shareholders and original backers, including New Leaf Venture Partners, have "lost faith: in Transcept President and CEO Glenn Oclassen.
"We will continue to hold this board responsible to its shareholders and to the growing chorus of voices demanding it not pursue an acquisition," Roumell wrote. "In light of Retrophin's opening offer, it is clear that there is interest in Intermezzo and highly probable that more interest can be found at higher prices," Roumell wrote.
The company earlier Wednesday said it would license an experimental acute migraine treatment from Shin Nippon Biomedical Laboratories Ltd. of Tokyo. As part of that deal, Transcept will pay $1 million upfront, development milestones totaling $6.5 million and, if approved by the Food and Drug Administration, commercial milestones totaling up to $35 million a year plus low double-digit royalties.
The treatment, dubbed TO-2070, uses dihydroergotamine, which has been approved in the United States since 1946. Transcept hopes to offer it as a nasal powder, instead of by injection, liquid nasal sprays or inhaling it into the lungs.
Transcept stock, which dipped 6 cents Wednesday to $3.69 per share, was up 21 cents to $3.90 in after-hours trading.
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I initially suspected he might try to manipulate the stock price by driving it up and then short selling to make a profit.
Clinuvel is worth $10 at least
@MartinShkreli at least $10 now if would provide some timings of when they plan to submit their NDA to the FDA it would bring more clarity
@MartinShkreli Couldn't agree more. Been in 7 years. Rarely has someone had the chance for such a clean mathematical bet.
@MartinShkreli Have you studied the p53 activating properties of Scenesse ?
@MartinShkreli agree on $clvly. I believe we will see much higher offers in the next 60 days. Maybe apply for FDA approval too
@farmazutical that doesn't make any sense... I know everything about acth and it has nothing to do with p53
@farmazutical not interested in this stupidity.
...
Holy poop I can't beleive he actually said "I know everything about acth" and then showed his ass in the same post. Simple google search of p53 and a-msh for terms would have saved him a ton of embarrassment. This dude is toxic and dangerous to be associated with in business.
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He's a prick.
NEW YORK (TheStreet) -- In the weeks before his ouster as the CEO of Retrophin (RTRX) , Martin Shkreli was buying relatively small amounts of the company's shares on the open market and using his personal Twitter account to convince investors to do the same.
"Not selling $RTRX. The stock is very very cheap. The revenue generating assets alone are worth [greater than] $25/share," Shkreli tweeted on Sept. 30, the day his departure from the embattled drug maker was announced.
But while talking up Retrophin's prospects publicly and buying some of the stock, Shrekli was selling privately a much larger portion of his drug company holdings. Without public disclosure, Shkreli received almost $3 million in gross proceeds by selling "forward contracts" on his Retrophin stock in early September, according to a filing with the Securities & Exchange Commission made public Monday night.
Shkreli's decision to sell Retrophin stock while telling shareholders and the public he was only a buyer contributed to the board's decision to fire him as CEO on Sept. 30, according to a source familiar with the matter.
Publicly, Retrophin's board has never cited specific reasons for its decision to oust Shkreli, although "stock-trading irregularities and other violations of securities rules" were said to play a role, according to a Bloomberg Businessweek story published the day after Shkreli's departure was announced.
Shkreli has not been accused of breaking any securities laws during his time at Retrophin. Last August, Retrophin's board admonished Shkreli for a series of inappropriate Twitter posts and the discovery that company employees were using alias Twitter accounts to promote Retrophin stock and make short-sale recommendations on other biotech stocks.
The new disclosure detailing Shkreli's selling of Retrophin shares comes at a delicate time. The former hedge fund manager has tried to restore his credibility and tamp down talk about his behavior and executive decision-making by blaming Retrophin's problems -- and his exit -- on the company's board and reporting by the media. At the same time, Shkreli is trying to raise outside investor money to finance a new company, Turing Pharmaceuticals.
For its part, Retrophin is trying to move past the turbulent times caused by its founder and former CEO and stop the slide in its stock price, which is down 63% since April. Retrophin's board installed former Chief Operating Officer Stephen Aselage as the new CEO. A Retrophin spokesman, reached Monday night, declined to comment on Shkreli or his sales of company stock.
Shkreli did not respond to a text seeking comment for this story.
Here's how Shkreli received almost $3 million in proceeds by selling Retrophin shares with delayed public disclosure:
On Sept. 9, Shkreli and an unnamed third party entered into a "prepaid forward contract" under which Shkreli promised to hand over 123,000 shares of Retrophin in two years. In exchange, the third-party buyer paid $1.07 million in cash to Shkreli -- an amount equivalent to 68% of the present value of the pledged Retrophin shares.
Retrophin (NASDAQ:RTRX) traded up 5.22% on Monday, hitting $8.67. 691,405 shares of the company’s stock traded hands. Retrophin has a one year low of $5.35 and a one year high of $24.25. The stock’s 50-day moving average is $9.89 and its 200-day moving average is $11.35. The company’s market cap is $228.2 million.
Retrophin (NASDAQ:RTRX) last released its earnings data on Thursday, November 13th. The company reported ($0.53) EPS for the quarter.
Retrophin Inc (NASDAQ:RTRX), formerly Desert Gateway, Inc, is a biotechnology company.
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Consulting Agreements. Between September 2013 and March 2014, the Company entered into several consulting agreements and releases with individuals or entities that had been investors in investment funds previously managed by Mr. Shkreli (the “MSMB Entities”), or that otherwise had financial dealings with Mr. Shkreli. The agreements provided for the issuance of a total of 612,500 shares of common stock of the Company, and a total of $400,000 in cash payments by the Company. The Oversight Committee concluded that the Company should not continue to treat these agreements as consulting agreements because their predominant purpose appears to have been to settle and release claims against the MSMB Entities or Mr. Shkreli personally, and not to provide meaningful and sustained consulting services to the Company.And
Litigation Settlements. In the second quarter of 2014, the Company settled two lawsuits involving individuals who had formerly performed services for both the Company and the MSMB Entities. The Oversight Committee concluded that approximately $200,000 in cash payments made by the Company as part of these settlements appear to have been made to cause these individuals to transfer 176,388 shares of the Company’s common stock directly to Mr. Shkreli.
Turing Pharmaceuticals AG, a New York City-based biopharmaceutical firm, has officially launched and has made three acquisitions for its commercial operations and development pipeline. The company also introduced its senior management team.
Turing's founder and executive chairman is Martin Shkreli, who has a history of success in the drug industry as founder and former CEO of Retrophin, Inc. At Retrophin, Mr. Shkreli led the acquisition of three key products in the six months following the company's initial public offering in 2014. In addition to Mr. Shkreli, Turing has assembled a management team comprised of senior executives with experience in the drug industry. Howard Dorfman was named senior vice president and general counsel; Mr. Dorfman formerly worked at Ferring Pharmaceuticals and Bayer Pharmaceuticals (US) as well as at law firm Ropes & Gray. Hass Patel was named vice president for chemistry, manufacturing and controls; Dr. Patel was previously with Pharmasset, Reliant Pharmaceuticals and GlaxoSmithKline. Nicholas Pelliccione, PhD, was named vice president of regulatory affairs; Dr. Pelliccione was formerly with Schering-Plough, Regado Biosciences, Aeterna Zenaris, and Chugai Pharma USA. Michael Harrison was appointed chief financial officer. Mr. Harrison was formerly with Retrophin. Nancy Retzlaff was named chief commercial officer; Ms. Retzlaff joins in early March from Mesoblast Ltd. She was previously with Pfizer, Schering-Plough and Bayer. Megan Roberts, PhD was named vice president and product feader for Vecamyl; Dr. Roberts previously worked at Genentech and BioMarin.
Simultaneous to its launch, Turing announced the acquisition of three assets from Retrophin: an intranasal formulation of ketamine, Syntocinon (oxytocin nasal solution), and Vecamyl (mecamylamine HCl tablets).
Turing is developing its new intranasal formulation of ketamine for a variety of psychiatric indications. The company is making investments in a novel delivery mechanism and other innovations to develop ketamine for the treatment of several serious psychiatric conditions and expects to commence clinical trials in the coming year. Turing's plans further include a development program for Syntocinon in addressing multiple indications across several therapeutic areas.
Turing's strategic focus is to acquire and advance development of external compounds while also pursuing internal drug discovery through proprietary research and developmeny. Turing has also acquired two early-stage compounds to be developed for various orphan drug indications.
Source: Turing Pharmaceuticals
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RTRX > SEC Filings for RTRX> Form 10-K on 11-Mar-2015 | All Recent SEC Filings |
Form 10-K for RETROPHIN, INC.
11-Mar-2015
Annual Report
The following discussion should also be read in conjunction with our audited consolidated financial statements, including the notes thereto.
Overview
Business and Recent Developments
We are a fully integrated biopharmaceutical company with approximately 110 employees headquartered in San Diego, California focused on the development, acquisition and commercialization of therapies for the treatment of serious, catastrophic or rare diseases.
During the first quarter of 2014, we completed the acquisition of all of the membership interests of Manchester Pharmaceuticals LLC ("Manchester"), a privately-held specialty pharmaceutical company that focuses on treatments for rare diseases. This acquisition expanded our ability to address the special needs of patients with rare diseases.
On May 29, 2014, we entered into a license agreement with Mission Pharmacal Company ("Mission"), a privately-held healthcare medications and treatments provider, for the U.S. marketing rights to Thiola� (tiopronin) which added Thiola� to our product line. In July 2014, we amended the license agreement to secure the Canadian marketing rights to the product. During 2014, the Company built a specialty commercial team to launch and commercialize these products.
As of December 31, 2014, we sold the following three products:
� Chenodal�, which is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age.
� Vecamyl, which is approved in the United States for the treatment of moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension.
� Thiola�, which is approved in the United States for the prevention of cysteine (kidney) stone formation in patients with severe homozygous cystinuria.
On January 9, 2015, the Company entered into an asset purchase agreement with Turing Pharmaceuticals pursuant to which the Company sold Turing Pharmaceuticals its ketamine licenses and assets (the "Assets") for a purchase price of $1.0 million. Turing Pharmaceuticals will also assume all future liabilities related to the Assets. Martin Shkreli, the Company's former Chief Executive Officer, is the Chief Executive Officer of Turing Pharmaceuticals (see Item 13. for Related Party Transactions).
On January 12, 2015, the Company announced the signing of a definitive agreement under which Retrophin has acquired the exclusive right to purchase from Asklepion, all worldwide rights, titles, and ownership of cholic acid for the treatment of bile acid synthesis defects, if approved by the U.S. Food and Drug Administration ("FDA"). Under the terms of the agreement, Retrophin paid Asklepion an upfront payment of $5.0 million and up to $73.0 million in milestones based on FDA approval and net product sales, plus tiered royalties on future net sales of cholic acid. Retrophin has secured a line of credit from current lenders to cover necessary payments.
On January 12, 2015, the Company entered into Amendment No. 3 ("Amendment No. 3") to the Credit Facility in which the Company obtained a commitment letter from Athyrium Capital Management, LLC and Perceptive Credit Opportunities Fund, LP (collectively, the " Lenders "), the Company's existing lenders, providing a commitment for a senior secured incremental term loan under the Company's existing term loan facility in an aggregate principal amount of $30 million (the "Incremental Loan"), which can be drawn down at the Company's option to finance the acquisition of the Acquired Assets. The Company's ability to draw down the Incremental Loan in the future is subject to various conditions and the negotiation and execution of a binding definitive amendment to the Company's existing term loan agreement for the Incremental Loan, and there can be no assurances that this will happen.
On February 13, 2015, Retrophin, Inc., its wholly-owned subsidiary Manchester Pharmaceuticals LLC and its other wholly-owned subsidiary Retrophin Therapeutics International, LLC (collectively, the "Sellers"), entered into a purchase agreement with Waldun Pharmaceuticals, LLC ("Waldun"), pursuant to which the Sellers sold Waldun their product rights to mecamylamine hydrochloride (also referred to as Vecamyl) (the "Vecamyl Product Rights") for a purchase price of $0.7 million. Waldun in turn sold the Vecamyl Product Rights to Turing Pharmaceuticals. In connection therewith, on February 13, 2015, the Company and Manchester entered into an asset purchase agreement with Turing Pharmaceuticals, pursuant to which the Company and Manchester sold Turing Pharmaceuticals their mecamylamine hydrochloride inventory (the "Inventory") for a purchase price of $0.3 million. Turing Pharmaceuticals will also assume certain liabilities related to the Vecamyl Product Rights and the Inventory.
Additionally, on February 13, 2015, the Company entered into an asset purchase agreement with Turing Pharmaceuticals pursuant to which the Company sold Turing Pharmaceuticals its Syntocinon licenses and assets, including related inventory, for a purchase price of $1.1 million. Turing Pharmaceuticals will also assume certain liabilities related to the Syntocinon licenses and assets.
In January 2015, our board of directors appointed an Oversight Committee of the board of directors (the "Oversight Committee"). The Oversight Committee concluded that certain of the transactions were consummated without specific approval of our board of directors or without our board of directors knowing all of the relevant facts. As a result, the financial statements contained in the Company's Form 10-Q for
the three months ended September 30, 2013 (the "2013 Q3 Form 10-Q"), the Company's Form 10-K for the year ended December 31, 2013 (the "2013 Form 10-K") and the Company's Forms 10-Q for the quarters ended March 31, 2014, June 30, 2014 and September 30, 2014 (the "2014 Forms 10-Q") contained errors related to certain of the consulting agreements, the predominant purpose of which appears to have been to settle and release claims against the MSMB Entities or Mr. Shkreli personally. On February 19, 2015, our board of directors concluded that as a result of the errors related to such consulting agreements, the financial statements contained in the 2013 third quarter Form 10-Q and the 2013 Form 10-K should no longer be relied upon.
We held a Special Meeting of Stockholders on February 3, 2015, at which our stockholders voted to approve a proposal ratifying the prior issuance of stock options to purchase 1,928,000 shares of common stock and 230,000 restricted shares of common stock granted to employees between February 24, 2014 and August 18, 2014 (the "Ratified Equity Grants"). The 2014 Forms 10-Q contain errors related to the non-cash compensation expense recognized in connection with the Ratified Equity Grants, because the grant/measurement date of the Ratified Equity Grants for financial accounting purposes did not occur until their ratification. We believe that the errors in the 2014 Forms 10-Q related to the non-cash compensation expense recognized in connection with the Ratified Equity Grants do not cause the financial statements included within the 2014 Forms 10-Q to be misleading, and therefore such financial statements can still be relied upon. We have corrected such errors, including any related disclosures, in this Annual Report on Form 10-K, and will restate those quarters in future Forms 10-Q filings.
Plan of Operation
Our plan of operation is to continue implementing our business strategy, including the continued commercialization and expansion of Chenodal� and Thiola� as well as the clinical development of our drug candidates, focusing primarily on the development of sparsentan for the treatment of FSGS, RE-024 for the treatment of PKAN, and RE-034 for the treatment of NS. We also intend to expand our drug product portfolio by acquiring additional drugs for marketing or development. During the next 12 months, our principal expenditures may include the following:
� We expect to incur operating expenses, including reduced research and development and selling, general and administrative expenses.
� We expect to incur product development expenses, including the costs incurred with respect to applications to conduct clinical trials in the United States for our three clinical candidates and the costs of ongoing and planned clinical trials. We expect to conduct multiple clinical trials for our assets, including our ongoing Phase 2 clinical trial for sparsentan for the treatment of FSGS, and a Phase 1 clinical trial for RE-024 for the treatment of PKAN. Certain European and South American health regulators have approved the initiation of dosing RE-024 in PKAN under physician initiated studies and we intend to file a U.S. IND in fiscal 2015. We are currently exploring options relating to the future development of RE-034. The expected costs associated with these trials amount to approximately $6-$8 million through December 2015.
� In addition, we intend to use clinical research organizations and third parties to perform our clinical studies and manufacturing. At our current and desired pace of commercialization and clinical development of our drugs, through December 2015, we cannot which amounts will be sufficient to fund our operations over the course of the next two years and we may need to expend significantly greater amounts to accomplish our goals. The Company through prudent expense management, expects to generate positive operating cash flows by the end of fiscal 2015.
Products and Research and Development Programs
Changes to Product and Research and Development Programs
In conjunction with the sale of the Company's Vecamyl, Syntocinon and ketamine licenses to Turing Pharmaceuticals, the Company has stopped future investment in these products.
Chenodal� (chenodiol tablets)
Chenodal� is a synthetic oral form of chenodeoxycholic acid, a naturally occurring primary bile acid synthesized from cholesterol in the liver, indicated for the treatment of radiolucent stones in well-opacifying gallbladders in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age.
On March 26, 2014, we completed the acquisition of Manchester Pharmaceuticals including the U.S. rights for Chenodal� and the intellectual property to develop, manufacture, and sell the product in the United States. We will continue to supply Chenodal� to the U.S. market.
We are exploring the steps necessary to gain U.S. Food and Drug Administration ("FDA") approval of Chenodal� for the treatment of cerebrotendinous xanthomatosis ("CTX"), a rare autosomal recessive lipid storage disease for which there are no FDA approved treatments. We are exploring options related to the development of Chenodal� for other indications.
Thiola� (Tiopronin)
Thiola� is approved by the FDA for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones. The resulting long-term damage can cause loss of kidney function in addition to substantial pain and loss of productivity associated with renal colic and stone passage. The worldwide prevalence of the disease is believed to be one in 7,000. We have built a salesforce to promote Thiola� to targeted physicians.
RE-024
We are developing RE-024, a novel small molecule, as a potential treatment for pantothenate kinase-associated neurodegeneration ("PKAN"). PKAN is a genetic neurodegenerative disorder that is typically diagnosed in the first decade of life. Consequences of PKAN include dystonia, dysarthria, rigidity, retinal degeneration, and severe digestive problems. PKAN is estimated to affect 1 to 3 persons per million. There are currently no viable treatment options for patients with PKAN. RE-024 is a phosphopantothenate prodrug therapy that aims to restore levels of this key substrate in PKAN patients. Certain ex-US health regulators have approved the initiation of dosing RE-024 in PKAN under physician-initiated studies in accordance with local regulations in their respective countries. The Company intends to file a U.S. IND in 2015 to support the initiation of company-sponsored studies.
Sparsentan
Sparsentan, formerly known as RE-021, is an investigational therapeutic agent which acts as both a potent angiotensin receptor blocker, or ARB, which is a type of drug that modulates the renin-angiotensin-aldosterone system and is typically used to treat hypertension, diabetic nephropathy and congestive heart failure, as well as a selective endothelin receptor antagonist ("ERA"), which is a type of drug that blocks endothelin receptors, preferential for endothelin receptor type A. We have secured a license to sparsentan from Ligand and Bristol-Myers Squibb (who referred to it as DARA). We are developing sparsentan as a treatment for FSGS. FSGS is a leading cause of end-stage renal disease and NS. We are currently enrolling patients for a Phase 2 clinical study of sparsentan for the treatment of FSGS and we expect approximately 100 patients to be enrolled.
RE-034 (Tetracosactide Zinc)
RE-034 is a synthetic hormone analog of the first 24 amino acids of the 39 amino acids contained in ACTH formulated using a novel process by Retrophin. RE-034 exhibits the same physiological actions as endogenous ACTH by binding to all five melanocortin receptors (pan-MCR), resulting in its anti-inflammatory and immunomodulatory effects. Retrophin has successfully formulated and manufactured RE-034 at proof-of-concept scale using a novel formulation process that allows modulation of the release of the active ingredient from the site of administration. Retrophin continues preclinical development of RE-034 to enable multiple strategic options, which may include the initiation of IND-enabling studies in 2015.
Financial Overview
Compensation and Related Costs
Compensation and related costs include salaries, bonuses and benefits to our executives and employees and non-cash stock based equity compensation and stock options for our employees.
Professional Fees
Professional fees include; research and development fees for drug candidates (RE-021, RE-024 and RE-034) for the treatment of FSGS, PKAN and NS and evaluation of potential new technologies; legal expenses related to licensing and product acquisition, employment and consulting agreements and general corporate work; consulting fees; accounting fees; and public and investor relations fees.
Research and Development Costs
Research and development include consulting fees and expenses related to RE-021, RE-034 and RE-024 and our other pipeline programs. Our research and development costs are comprised of salaries and bonuses, benefits, non-cash stock-based compensation, license fees, milestones under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, and develop drug materials and delivery devices; and associated overhead expenses and facilities costs. Reimbursed research and development costs under collaborative arrangements are recorded as a reduction to research and development costs. We charge direct internal and external program costs to the respective development programs. We also incur indirect costs that are not allocated to specific programs because such costs benefit multiple development programs and allow us to increase our pharmaceutical development capabilities. These consist primarily of facilities costs and other internal shared resources related to the development and maintenance of systems and processes applicable to all of our programs.
Research and development expenses represent costs incurred to conduct research of our proprietary product candidates. We expense all research and development costs as they are incurred. Our research and development expenses consist of employee salaries and related benefits, including stock-based compensation, third-party contract costs relating to research, manufacturing, preclinical studies, clinical trial activities, regulatory activities, laboratory consumables, and allocated facility costs.
At any point in time, we typically have various early stage research and drug discovery projects. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery project and are typically deployed across multiple projects. As such, we do not maintain information regarding these costs incurred for these early stage research and drug discovery programs on a project-specific basis.
We routinely engage vendors and service providers for scientific research, clinical trial, regulatory compliance, manufacturing and other consulting services. We also make grants to research and non-profit organizations to conduct research which may lead to new intellectual properties that we may subsequently license under separately negotiated license agreements. Such grants may be funded in lump sums or installments.
The following table summarizes our research and development expenses during the years ended December 31, 2014, 2013 and 2012. The internal costs include personnel, facility costs, laboratory consumables and discovery and research related activities associated with our pipeline. The external program costs reflect external costs attributable to our clinical development candidates and preclinical candidates selected for further development. Such expenses include third-party contract costs relating to manufacturing, clinical trial activities, translational medicine and toxicology activities.
December 31, December 31, December 31, 2014 2013 2012 External service provider costs: Sparsentan $ 7,448,486 $ 2,443,273 $ 297,833 RE-024 11,174,890 1,548,957 124,635 Syntocinon 3,353,416 250,540 - RE-034 3,236,796 230,279 - General 7,077,448 159,080 240,034 Other product candidates 1,829,218 1,117,771 - Total external service provider costs: 34,120,254 5,749,900 662,502 Internal personnel costs: 13,674,969 1,334,109 - Total research and development $ 47,795,223 $ 7,084,009 $ 662,502 |
We expect our research and development expenses to decrease during fiscal 2015 as we focus our progress on our key product candidates, advance our discovery research projects into the preclinical stage and continue our early stage research. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for any of our product candidates. The probability of success of each product candidate may be affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability.
Most of our product development programs are at an early stage; therefore, the successful development of our product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. Given the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical trials of our product candidates or if and to what extent we will generate revenues from the commercialization and sale of any of our product candidates.
Selling, General and Administrative
Selling, general and administrative expenses consist of compensation, professional fees, rent, depreciation and amortization, settlement charges (see Note 2 to financial statements), travel and entertainment, recruiting, insurance, business development, advertising, and other operating expenses. We expect to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations applicable to companies listed on a national securities exchange and costs related to compliance and reporting obligations pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC").
Other Expenses
Other expenses consist of the change in fair value of derivative financial instruments, interest income and expense, finance expense and realized gains and losses on the sale of marketable securities.
License Agreements
Novartis
On December 12, 2013, we entered into an agreement with Novartis and Novartis AG pursuant to which Novartis and Novartis AG agreed to grant us an exclusive, perpetual, and royalty-bearing license for the manufacture, development and commercialization of Syntocinon and related intranasal products in the United States (the Syntocinon License Agreement"). Under the license, Novartis and Novartis AG are obligated to transfer to us certain information that is necessary for or related to the development or commercialization of Syntocinon. We are responsible for conducting research and preclinical, clinical and other development of Syntocinon at our own expense, and must use commercially reasonably efforts to develop Syntocinon in the United States.
As consideration for the license, we paid to Novartis and Novartis AG a $5 million upfront fee and are required to pay annual maintenance fees of $3.0 million after each anniversary until there has been regulatory approval, up to $34 million in developmental milestones for the first indication and up to $32.0 million in developmental milestones for the second indication. Should we commercialize Syntocinon, we will be obligated to pay Novartis and Novartis AG a 10%-20% royalty on net sales of such products. We are also
required to pay annual maintenance fees to Novartis and Novartis AG. The license agreement contains other customary clauses and terms as are common in similar agreements in the industry.
On February 13, 2015, the Company entered into an asset purchase agreement with Turing Pharmaceuticals pursuant to which the Company sold Turing Pharmaceuticals its Syntocinon licenses and assets. Turing Pharmaceuticals will also assume certain liabilities related to the Syntocinon Assets, including the balance of the payments due under the Syntocinon License Agreement.
Ligand
In February 2012, we entered into an agreement pursuant to which Ligand agreed to grant us a worldwide license for the development, manufacture and commercialization of sparsentan, an angiotensin receptor blocker and a selective endothelin receptor antagonist which we are initially using in connection with the treatment of FSGS. Under the license agreement, Ligand granted us a sublicense under certain of its patents and other intellectual property in connection with the development and commercialization of sparsentan and related compounds. Under the license agreement, Ligand is obligated to transfer to us certain information, records, regulatory filings, materials and inventory controlled by Ligand and relating to or useful for developing sparsentan. We must use commercially reasonable efforts to develop and commercialize sparsentan in specified major market countries and other countries in which we believe it is commercially reasonable to develop and commercialize such products.
As consideration for the license, we are required to make substantial payments payable upon the achievement of certain milestones totaling up to $105.5 million. Should we commercialize sparsentan or any related compound, we will be obligated to pay to Ligand an escalating annual royalty between 15% and 17% of net sales of all such products. In the event that we desire to enter into a license arrangement with respect to sparsenten or any related compound, Bristol-Myers Squibb will have a right of first negotiation and Ligand will have a right of second negotiation with respect to any such license arrangement for a licensed compound. The license agreement contains other customary clauses and terms as are common in similar agreements in the industry. Through December 31, 2014, we made payments to Ligand of $2.5 million under the license agreement.
Thiola� License Agreement
On May 29, 2014, the Company entered into a license agreement with Mission, pursuant to which Mission agreed to grant the Company an exclusive, royalty-bearing license to market, sell and commercialize Thiola� in the United States and a non-exclusive license to use know-how relating to Thiola� to the extent necessary to market Thiola�. In July 2014, the Company amended the license agreement with Mission to secure the Canadian marketing rights to the product for no additional consideration.
Upon execution of the agreement, the Company paid Mission an up-front license fee of $3.0 million. In addition, the Company shall pay guaranteed minimum royalties during each calendar year the greater of $2.0 million or twenty percent (20%) of the Company's net sales of Thiola� through June 30, 2024. As of December 31, 2014, the present value of guaranteed minimum royalties payable is $11.6 million using a discount rate of approximately 11% based on the Company's current borrowing rate. As of December 31, 2014, the guaranteed minimum royalties' current and long term liability is approximately $0.7 million and $10.9 million, respectively, and is recorded as other liability in the consolidated balance sheet. The Company capitalized $15.0 million related to the Thiola� asset which consists of the up-front license fee, professional fees, present value of the guaranteed minimum royalties and payments in fiscal 2014 in excess of guaranteed minimum royalties.
Other Matters
Investigation
In September 2014, our board of directors requested that the Company's outside legal counsel conduct an investigation (the "Investigation") into the circumstances surrounding the negotiation and execution by the former Chief Executive Officer of the Company, Martin Shkreli, of certain consulting and settlement agreements entered into by the Company. The Investigation also covered additional agreements and other matters involving Mr. Shkreli during his tenure as the Chief Executive Officer of the Company.
In January 2015, our board of directors appointed an Oversight Committee of the board of directors (the "Oversight Committee"), consisting of Gary Lyons and Jeffrey Meckler, each of whom was not a member of our board of directors during the period of time covered by the Investigation. Our board of directors delegated to the Oversight Committee the independent and plenary authority to oversee and direct the Investigation and make findings and decisions related to the Investigation.
The following information is the Oversight Committee's conclusions to date:
� Between September 2013 and March 2014, the Company entered into several consulting agreements and releases with individuals or entities that had been investors in investment funds previously managed by Mr. Shkreli (the "MSMB Entities"), or that otherwise had financial dealings with Mr. Shkreli. The agreements provided for the issuance of a total of 612,500 shares of common stock of the Company, and a total of $400,000 in cash payments by the Company. The Oversight Committee concluded that the Company should not continue to treat these agreements as consulting agreements because their predominant purpose appears to have been to settle and release claims against the MSMB Entities or . . .
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By Jacob Batchelor
Law360, New York (December 18, 2014, 6:28 PM ET) -- The former CEO of biopharmaceutical company Retrophin Inc. handed out stock without shareholder approval and misrepresented the company's finances, according to a recent securities class action filed in New York federal court.Orphan drug outfit Retrophin ($RTRX) pulled off a quite a quick return on its latest investment. In March, the company paid about $75 million to pick up a small drugmaker, a just-approved product and a voucher promising its holder a quick trip through the FDA review process. Now the San Diego-headquartered biotech is selling that coupon to Sanofi ($SNY) in a $245 million deal, affirming the escalating value of a speedy approval.
Under the agreement, Sanofi will pay Retrophin $150 million up front in exchange for the biotech's Rare Pediatric Disease Priority Review Voucher, handing over installments of $47.5 million in 2016 and 2017. The voucher, awarded to developers of treatments for rare childhood disorders, guarantees its user a 6-month FDA review, cutting short the standard 10-month process.
The voucher program is designed to incentivize R&D in rare and neglected diseases by giving companies a desirable asset that can be sold to the highest bidder. And Retrophin's sale, the third in the program's history, fetched by far the highest price tag. Gilead Sciences ($GILD) bought a voucher for $125 million last year, and Sanofi and Regeneron ($REGN) owe their first-mover status in a new field of cholesterol drugs to the $67.5 million they spent on one months earlier.
Disclosure: I am/we are short RTRX. (More...)I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
Small drug companies are rarely priced according to their book value. Their value begins with the risk and reward of their pipeline, which form the basis for predicting a book value. However, when virtually the entirety of a company's operations comes from recent acquisitions, the book value should be close to its market capitalization.
For example, I start my company "Buyout Drugs Inc." with $100 million in cash. I spend it all on acquiring smaller companies, drugs, or licenses. Assuming the free market prices these things accurately, I haven't done anything to increase the value of my company. After the buying spree, the book value of Buyout Drugs Inc. is still just $100 million and the stock should trade at a price/book ratio of one. This will change as the poker hand, AKA "the pipeline," plays out, but the more recent the acquisition, the more accurately the balance sheet reflects the company's value.
Consider Retrophin (NASDAQ:RTRX), a company which has done, more or less, exactly what I describe above. On that basis, Retrophin's stock is worth $9.10 per share. It currently trades upwards of $30. I find it a tad overvalued.
Looks like Martin Skhreli should have deleted his emails and then overwrote them! I think he is caught, and may have to do it again by taking money from Turiing.
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Martin Shkreli |
Turing Pharmaceuticals, led by an outspoken former hedge fund manager, raised $90 million from its own CEO and some unnamed benefactors, at the same time buying a treatment for infectious disease to flesh out its pipeline.
The company, headquartered in New York and Switzerland, is the latest biotech play from Martin Shkreli, a stock picker turned biotech CEO whose first startup, Retrophin ($RTRX), forced him out last year. His latest venture, Turing, is similarly focused on buying up treatments for serious and underserved diseases, and the company says its $90 million raise will pave the way to executing its plan.
In an uncommon move, Shkreli himself led the Series A financing, and Turing isn't naming any of its other backers, calling them "preeminent institutional equity investors" and leaving it at that. In a filing with the SEC last week, Turing counted 34 individual participants in its funding round but reported raising just $62.7 million. A spokesman for the company declined to explain the $27.3 million difference, and further questions about the company's financials were met with a terse email from Shkreli asking FierceBiotech not to contact Turing again.
Join us for a deep dive into the pricing challenges and the best-practices you can follow to not only survive the new cost-out/value-in ecosystem trying to disrupt the Med Tech industry, but actually exploit these changes to establish competitive advantage. Register Now!
Meanwhile, Turing has already committed some of its new cash, this week paying Impax Laboratories ($IPXL) $55 million for the U.S. rights to Daraprim, an FDA-approved treatment for the parasitic disease toxoplasmosis. Turing says it plans to build out a pipeline of therapies for the infection, which the CDC sites as the second leading cause of death by foodborne illness.
Since founding Turing last year, Shkreli has taken a page from what made Retrophin a high-profile--and controversial--player among small biotech companies. Retrophin's stated goal was ferreting out value in biopharma by acquiring assets with potential in rare and neglected diseases, a process that can mean acquiring an underused drug and jacking up its cost to take advantage of rare disease pricing.
Shkreli's tenure at Retrophin came to an end in October when his board ousted him amid accusations of stock impropriety and concerns about his occasionally brash Twitter persona. But he managed to take three Retrophin assets with him on the way to founding Turing, picking up a hypertension drug his new company believes could treat autism, an intranasal formulation of oxytocin and a ketamine spray in development for depression. Moving forward, Turing will operate much like Retrophin, looking "to buy dollar bills for 50 cents," as Shkreli told Forbes in February.
And Turing's latest fundraise is "a great reflection on our business model," the CEO said in a statement Monday.
"We plan to accelerate clinical trials for several treatments and are pleased to announce an immediate addition to our portfolio," he said. "We look forward to the continued execution of our plan to bring new treatments for serious diseases to patients, helping us maximize shareholder value."
- read the statement
- here's Turing's filing
Related Articles:
Retrophin slips on liver woes in rare disease drug's first trial
Retrophin soars on its latest rare disease play
Retrophin plots a $40M IPO amid a spree of deals
Though it is common sense you can't rob Peter to pay Paul but apparently you can if your lawyer says you can get away with it., Skhreli defense is that his corporate lawyer told him he could do it. All dependent on what emails evidence is.
The prosecution should perhaps have sought a lesser charged crime as intent is an abstract in the mind of in this case Skhreli. Common sense does not matter with intent. Skhreli corporate lawyer was charged also criminally, which I think adds validity to Skhreli defense. Prosecution can't have both.
To note, the prosecution has no idea at the time its charges are filed how a defense legal team will evaluate to counter.
My guess is Skhreli is not guilty at least on this serious charge.
Mostly, it is not unlawful to lie (except to a federal agent) and Skhreli did make false statements from prosecutions point of view, but human social communication is nothing but factual statements with subjective interpretations, degrees of facts, contextual opinions, exaggerations, and even word semantics. And then there's the essence of the moment of a lie. And it's not a lie if the one stating it at the time believes it.
And I think the jurors will see thru the motive of prosecution is that they are out to get Skhreli because he is public figure who raised an AIDS drug %5000 and they can not prosecute this as a crime.
And all those jurors are on that case because they want to be on it. All it takes is one of them to identify with Skhreli (different or eccentric or unconventional or weird ) or be of nature to be anti-establishment or anti authority type whom not so much wants to assess facts of case or even help skhreli but just wants to stick it to government.
I think Skhreli's fate has already been determined when his defense picked over the jurors and the prosecution was less astute at strikes. And it says a lot that the SEC and Feds were aware and informed of what they are now prosecuting Skhreli for and declined prosecuting for years till he became a public figure who raised drug prices. And Skhreli fits, acts and purveys a cliche villain.
I think Skhreli and his researchers did their homework with Clinuvel. And they timed their Retrophen accumulation of stock and press tuned with EMA decision with an expectation that Clinuvel stock upon approval of drug would go up much more than it did. They did not have a monetary feasible or lawful route to takeover Clinuvel under ASX regulations. It was a greenmail and it did not even nudge the price much of stock.
Maybe next year Clinuvel should announce a %5000 increase in the price of Scenesse and that will get the markets attention.
And how do you "give" Skhreli 's Turing pharma startup two "useless" drugs of Retrophen that no board member ever resigned nor attempted to correct the Retrophen publicly stating all along the value of these drug candidates.
This was a very bad presentation of a bad witness for the prosecution and is starting to show the prosecution has a bad case against Skhreli. If one juror thinks you are knowingly putting up an obviously untrthful accuser, than the juror is instructed at trial end with jury instructions to possibly disregard the entire testimony.
If the prosecution had a smoking gun email they would not be using witnesses with opinions, here say, innuendo, rumors, and interpretive circumstantial (lack) of evidence. They are trying to get a conviction because he is a ostentatious (a.......e) whom raised drug prices. Does not appear to be working, but you never know with jurors.
The prosecution is trying to use witnesses documents now without the witnesses, thereby not allowing Skhreli lawyers fundamental right to question accusers. No way judge will let happen or it's a good appeal for Skhreli for a mistrial.
The facts and the laws are all much more favoring Skhreli, BUT he is disliked by judge and public and jurors that they maybe do what's expected and find a guilty verdict in some count, BUT not likely in my opinion will they get nine jurors.
All this about Skhreli and Retrophen and timely to Clinuvel takeover attempt, yet no press for Clinuvel and nor and secondary interest.
My guess is Skhreli is found not guilty on all counts. The first three counts are strongest against him. Though Skhreli lost all the money his investors had in MSMB Capital, it appears he gave not money but peices of paper with an investment interest in his new startup Retrophen.
How do you prove he defrauded the so called victims whom got several times their investment. Skhreli could have just sent a financial statement and been lawful saying you invested in MSMB Capital and we invested per terms and lost all your money. Not exactly a Bernie Madoff, who also faked his trades and then his financial statements, a real Ponzi scheme stabaized.
But in reality, Retrophen was all on borrowed money, but the result is Skhreli actions in and after startup we're very fortuitous investments.
I do not think any reasonable juror, nor should prosecution have made the veracity here as the main witness against Skhreli.
I think there is 'reasonable doubt' going now into day five of deliberations of at least one juror . I think the jurors want to find Skhreli guilty on at least one count. On day two one of the two questions to judge was define intent on fraudulent intent charge. So at least one juror is saying they did not see proving of Skhreli intent. Though they surely see the fraud with backdating documents and sham agreements.
This appeared to be the strongest evidence against Skhreli and the victims whom got reimbursed by Retrophen for their MSMB losses admitted no consulting.
I assume Skhreli lawyer blamed it on the attorney Skhreli relied upon........my guess is Skhreli must have had some good email evidence between himself and his Retrophen lawyer.
The second question of jurors to judge was about assets under management meaning.........When the jurors can not even agree on the definition, they will not agree on a verdict
My guess is Skhreli is a hung jury and no verdict
Martin Shkreli was accused of duping hedge-fund investors.
He also was charged with ripping off the drug company he founded to repay investors.
Shkreli faces years in prison when sentenced.
Tough to appeal factual findings of jury. They heard evidence and decided he was lying. Even though the Press reports of "soft skin" testified by Retrophen Richards sounds not believable to me. Appeals have to be based on mistakes or inadvertence of judge not following law. Unusual that the press mentions ONLY three lies and no physical evidence. Stating he told an investor he went to Columbia, not that he held a degree ( Dr Wolgen bio states he went there) and such investor had to rely on this statement and invest, is thin for a charge or conviction. His word against Skhreli. Another witness says he relied on Skhreli stating he dropped out of college. From what I see about the public Skhreli he is not smart enough to conclude ahead of time that either statement and not along with a lot of other lies could entice these investors.
I think he was convicted because he is what everybody considers an A------------
I just saw Skhreli on news say it was a witchunt and they found broomsticks, blah, THEN HE just said he was DELIGHTED blah blah...................now that's a big lie.
Check out his Federal Inmate Identification number for the next seven years. http://www.newssummedup.com/summary/Martin-Shkreli%E2%80%99s-journey-from-pharma-executive-to-inmate-No-87850-053-kv6t97
And for one second, Martin inadvertently ran his camera past his computer, and Clinuvel is at $2.02
After he had contracts betting a stock would go down, he used legitimate but disporpotional and out of context negatives in yhe trials about a drug or technicality in the hige dossier and he filed complaints to the FDA. He also acknowledged in each letter he had a financial interest in that drugs stock. Thus disarming SEC questionable prosecutional success for violations.
Each time in the companys (Mallinkrodt was one, which was the melanocortin drug Synthactin) the FDA followed procedurals and protocolls and resulted in delays to FDA doing its MAA meeting.
My understanding.....
A short sale contract has a date that it ends and to profit the shortseller needs only for the stock price to go down from the date agreed purchase of contract, but this is not the date that the contract has to be settled. At anytime the shortseller can cashout with his profits prior to that deadline as the shortsale is a trading market.
If the deadline on the shortsale arrives and if the shortseller is still holding the contract and the stockprice is above the price struck in the contract, then the shortseller lets it expire and has not recovered what he payed to get the contract.
Imo the shortsellers have made a fortune in the several months they have been active in Clinuvel.