Stein Mart files for Chapter 11 bankruptcy

Stein Mart voluntarily files Chapter 11 bankruptcy protection

Stein Mart (SMRT) announced that it and its subsidiaries have filed voluntary petitions for relief under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Middle District of Florida – Jacksonville Division.

Stein Mart files for bankruptcy protection

Stein Mart offers designer and name-brand fashion apparels, home decor merchandise, accessories, and shoes at everyday discount prices in the United States. As of June 3, 2020, it operated 281 stores in 30 states. The company was founded in 1908 and is headquartered in Jacksonville, Florida.

The Company has filed customary motions with the Bankruptcy Court that will authorize, upon Bankruptcy Court approval, the Company’s ability to maintain operations in the ordinary course of business, including, among other things, the payment of employee wages and benefits without interruption, payment of suppliers and vendors in the normal course of business, and the use of cash collateral.

Too much savings caused Stein Mart’s demise

These motions are typical in the Chapter 11 process and the Company anticipates that they will be approved shortly after the commencement of its Chapter 11 case.

Details on the Company’s Chapter 11 process and go-forward strategy are as follows:

The Company expects to close a significant portion, if not all, of its brick-and-mortar stores and, in connection therewith, the Company has launched a store closing and liquidation process.

The Company, however, will continue to operate its business in the ordinary course in the near term; and the Company is evaluating any and all strategic alternatives, including the potential sale of its eCommerce business and related intellectual property. 

SMRT last traded at $0.18.

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Mohawk shares tumble on investors lawsuit

Mississippi Retirement System sues the carpet maker

In January, the Public Employees’ Retirement System of Mississippi filed a lawsuit claiming accounting fraud at Mohawk (MHK). The suit did not get a lot of attention at the time, but new filings submitted in late June add significant details about the allegations.

According to analysts, the filing includes testimony from a former Mohawk employee who claims the company has used fictitious sales to artificially boost revenue since 2017.

JPMorgan

JPMorgan analyst Michael Rehaut noted earlier that the Public Employees’ Retirement System of Mississippi, as part of a consolidated class action complaint filing dated June 29, gave “significant incremental details” regarding claims that Mohawk engaged in channel stuffing at the end of the quarter and intentionally overproduced product.

MPERS sues Mohawk Industries

While “the veracity of these accusations will likely not be determined until after an extended legal process” of several months if not longer, Rehaut sees the lawsuit as likely to remain an overhang on the stock until this matter concludes.

He also sees the “fairly granular level of detail across the allegations” and quotes from interviews with several former employees creating a higher level of risk for the company from this lawsuit, added the analyst, who keeps a Neutral rating on Mohawk shares.

SunTrust

A shareholder lawsuit filed earlier this year has recently added new court filings that allege multiple issues inside Mohawk Industries, the most damaging allegation being its revenue recognition practices which included shipping goods on the last day of the quarter and then having those as returns in the following quarter, SunTrust analyst Keith Hughes tells investors in a research note.

The allegations being made during the company’s quiet period “have hamstrung any response,” says Hughes, who admits “it is hard to say as an outsider whether these have merit at this point.” However, given the size of Mohawk, it would need “widespread practices to boost revenues via the method” alleged, adds the analyst, who keeps a Buy rating on Mohawk with a $119 price target.

Wells Fargo

Wells Fargo analyst Truman Patterson notes that the Public Employees’ Retirement System of Mississippi has filed a Class Action Complaint against Mohawk and CEO Jeff Lorberbaum, claiming the company engaged in a “fraudulent scheme to fabricate revenues through fictitious ‘sales’ of products that were not delivered to customers and to conceal from investors the true reasons for the company’s ballooning inventory,” damaging shareholders between April 2017 and July 2019.

While Mohawk stakeholders have known about the lawsuit since early January, filings have only recently become publicly available, which the analyst believes drove shares down on Wednesday. Patterson expresses no opinion on the validity of the allegations against the company, but acknowledges that they would clearly be a negative if proven to be true, likely damaging shareholder confidence in management. The analyst has an Underweight rating and an $80 price target on the stock.

The stock is down 19% to $74.10. The question now shifts to whether the allegations will result in a full SEC investigation.

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FDA rejects Intercept’s drug application, shares plunge

Intercept receives FDA CRL for obeticholic acid recommending additional data

Intercept Pharmaceuticals (ICPT) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis.

stockwinners.com ICPT
Shares plunge following FDA’s comments

The CRL indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.

NASH is the severe form of Non-Alcoholic Fatty Liver Disease (NAFLD). It can lead to liver cancer, cirrhosis, and liver transplants.

The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.

Intercept had previously disclosed that, based on the FDA’s decision to postpone a tentatively scheduled advisory committee meeting, it was expected that the Agency’s review of its NDA would extend beyond the PDUFA goal date and that the FDA would move forward with rescheduling the Adcom.

The NDA submission for OCA is the first for NASH and was based on data from 35 clinical trials and more than 1,700 NASH patients treated with the drug.

OCA is the only investigational NASH drug with Breakthrough Therapy designation and has uniquely demonstrated reproducible ability to reverse or otherwise stabilize liver fibrosis in patients with advanced fibrosis due to NASH.

According to the FDA draft guidance for NASH fibrosis, of the histologic features of NASH, fibrosis is considered the strongest predictor of adverse clinical outcomes, including liver-related death.

Estimated number of people suffering from fatty liver, Stockwinners

There is currently no approved therapy for this devastating disease, which has become a leading cause of liver failure and resulting poor clinical outcomes.

A number of other companies working on NASH treatments are also moving lower, with CymaBay (CBAY) down about 3% and NGM Biopharmaceuticals (NGM) fractionally lower.

Other companies exploring NASH treatments include Madrigal Pharmaceuticals (MDGL), Novo Nordisk (NVO), Genfit (GNFT), Eli Lilly (LLY), and Alnylam Pharmaceuticals (ALNY).

ICPT closed at $77.49, last traded at $48.00, down 38%.

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California Resources on the verge of bankruptcy!

The oil driller is preparing near-term bankruptcy filing, WSJ reports

California Resources Corporation (CRC) operates as an oil and natural gas exploration and production company in the State of California.

The company sells crude oil, natural gas, and natural gas liquids to marketers, California refineries, and other purchasers that have access to transportation and storage facilities. It holds interests in approximately 2.2 million net acres of mineral acreage. As of December 31, 2019, the company had net proved reserves of 644 million barrels of oil equivalent.

Interest Payment

California Resources skipped an interest payment to lenders and could file for bankruptcy as soon as next week, The Wall Street Journal’s Alexander Gladstone reports, citing people familiar with the matter.

The company said in an 8-K filing that it entered into forbearance agreements most of its lenders, who have agreed not to exercise “remedies” under the credit agreements. 

The oil driller said Monday it has entered into an agreement with a majority of its senior lenders to wait until Sunday before they can declare a default, the author notes.

2-Year price chart for CRC

The company has suffered from a sharp selloff in crude oil futures prices to start this year, as a result of the drop in demand from the COVID-19 pandemic and the price war between Saudia Arabia and Russia.

CRC is up 67 cents to $2.68.

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Iterum Therapeutics drug fails, shares cut in half

Iterum says Phase 3 trial of sulopenem did not meet primary endpoint

Iterum Therapeutics (ITRM) announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae 2 clinical trial in complicated urinary tract infection.

Iterum shares collapse following it’s drug failure

The primary U.S. Food and Drug Administration endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin.

The randomized, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults.

Patients were randomized to receive either IV sulopenem once daily for a minimum of five days followed by oral sulopenem twice daily to complete seven to ten days of treatment, or IV ertapenem once daily for a minimum of five days followed by either oral ciprofloxacin or, for quinolone resistant isolates, amoxicillin-clavulanate twice daily.

Responder rates at the test of cure visit for sulopenem were 67.8% and for ertapenem were 73.9% with a difference of -6.1%.

The difference in response rates was driven almost entirely by higher rates of asymptomatic bacteriuria on sulopenem relative to ertapenem, only evident at the test of cure visit; the rates of patients receiving additional antibiotics or with residual cUTI symptoms was similar.

Clinical response at the test of cure in the Modified Intent to Treat patient population and Clinically Evaluable patient population sulopenem vs ertapenem: 0.4% was similar.

The outcome at other secondary endpoints was also similar, including the overall response at the end of therapy visit at Day 10.

Strategic Alternatives

Based on the trial results, Iterum Therapeutics is evaluating its corporate, strategic and financial alternatives with the goal of maximizing value for its stakeholders while prudently managing its remaining resources.

These alternatives could potentially include the licensing, sale or divestiture of the company’s assets or proprietary technologies, a sale of the company, a merger or other business combination, another strategic transaction involving the company, restructuring activities, winding down of operations, dissolving and liquidating assets or seeking protection under bankruptcy laws.

ITRM shares are down 54% to $1.95.

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Minerva shares collapse following its drug failure

Minerva says Phase 3 trial of roluperidone did not meet primary endpoint

Minerva Neurosciences (NERV) announced that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary and key secondary endpoints.

Shares tumble following its drug failure

In total, 515 patients were enrolled into the trial, and 513 patients received treatment and were included in the safety and Intent-To-Treat population.

The trial was conducted in the USA, Europe and Israel.

There were 172 patients who received placebo, 172 patients who received roluperidone 32 mg, and 171 patients who received roluperidone 64 mg.

Demographic and baseline disease characteristics were comparable across all treatment arms.

The results for both roluperidone doses versus placebo across both the primary and the key secondary endpoints to Week 12 were corrected for multiplicity using the truncated Hochberg procedure.

The primary objective of the trial was to evaluate the change from baseline to Week 12 of NSFS with 32 mg and 64 mg doses of roluperidone compared to placebo in patients diagnosed with schizophrenia presenting with moderate to severe negative symptoms.

Neither the 32 mg nor 64 mg dose of roluperidone showed a statistically significant separation from placebo.

Furthermore, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, the change from baseline to Week 12 in PSP.

Schizophrenia destroys patient’s life

Although limited inferences can be drawn from this data, unadjusted statistically significant separations from placebo were observed in NSFS at Week 4 for both doses and at Week 8 for the 64 mg dose, and the 64 mg dose was statistically significantly different from placebo as measured by change in PSP at all other assessment timepoints.

Overall, subgroup analyses by region and by age groups were similar.

Roluperidone was generally well tolerated, and the incidences of patients who reported treatment-emergent adverse events over the duration of 12 weeks of treatment were 37% for the 64 mg group, 42% for the 32 mg group, and 33% for placebo.

Only 42 patients discontinued from the study due to adverse events, 16 in 64 mg arm, 18 in 32 mg arm, and 8 in placebo arm.

Two treatment-unrelated deaths were reported in the 32 mg treatment arm says Phase 3 trial of roluperidone did not meet primary endpoint.

NERV is down 82% to $2.50.

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Several retailers grab their shopping bags and file for bankruptcy

As JC Penney’s files for bankruptcy, others line up to do the same

Retailers have long been suffering from a tough retail environment due to competition from online retailers such as Amazon, Etsy and eBay; it seems like COVID-19 fired the kill shot.

J.C. Penney

J.C. Penney announced that it has received approvals from the U.S. Bankruptcy Court for the Southern District of Texas, in Corpus Christi, TX for the “First Day” motions related to the company’s voluntary Chapter 11 petitions filed on May 15, 2020, including approval for the company to access and use its approximately $500M in cash collateral.

The 118 year old retailer files for Chapter 11 bankruptcy, Stockwinners

J.C. Penney entered into a restructuring support agreement with lenders holding approximately 70% of J.C. Penney’s first lien debt to reduce the company’s outstanding indebtedness and strengthen its financial position. J.C. Penney has approximately $500M in cash on hand as of the Chapter 11 filing date.

James Cash Penney started the company in 1902

JCP Gets Delisted

The New York Stock Exchange announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of J.C. Penney Company – ticker symbol JCP – from the NYSE. NYSE Regulation reached its decision that the company is no longer suitable for listing after the company’s May 15, 2020 disclosure that the company filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code.

Recent Retail Bankruptcies

On May 4th, J.Crew Group announced it has reached an agreement with its lenders holding approximately 71% of its Term Loan and approximately 78% of its IPCo Notes, as well as with its financial sponsors, under which the company will restructure its debt and deleverage its balance sheet, positioning J.Crew and Madewell for long-term success.

Houston-based Stage Stores Inc. filed for chapter 11 bankruptcy in Texas last week.

GNC Holdings (GNC), the nutritional supplement retailer, avoided bankruptcy by reaching a last-minute deal with creditors that allows it to avoid bankruptcy for at least 30 days but no more than 90 days under a deal announced Friday.

GNC avoids bankruptcy for 90 days

True Religion

Even before COVID-19 forced True Religion to close its 87 stores, the denim specialist’s sales were in decline and its profits were negative. After shuttering its footprint in response to the pandemic, 80% of its sales disappeared, according to the company. 

Others on the list

According to Law.com, both Macy’s (M) and Neiman Marcus have hired bankruptcy law firm Kirkland, and Wachtell. Neiman filed for Chapter 11 last week. Macy’s should be forthcoming.

Pier 1 Imports (PIR) filed for bankruptcy protection this month. It would only make sense if it’s competitors follow the same path.

Nashville-based retailer, Kirkland’s, Inc. operates as a specialty retailer of home décor in the United States. The company’s stores provide various merchandise, including holiday décor, furniture, ornamental wall décor, decorative accessories, art, textiles, mirrors, fragrance and accessories, lamps, artificial floral products, housewares, outdoor living items,

Kirkland’s has avoided Chapter 11, Stockwinners

In 2019, seventeen major retailers filed for bankruptcy. For some of them it was their second trip to the alter including Payless, Gymboree, and Charming Charlie.

Some of the retailers that filed for bankruptcy in the past 18 months. Stockwinners

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In the market for a used car? You are in luck

A Hertz bankruptcy will flood the market with used vehicles

If you are in the market for a used car, you are in luck. That is, if you have a place to drive to!

According to the Detroit Press, used car prices fell 34.4 percent in April alone. The paper offers solace to it’s readers by mentioning that  used car prices could go up soon due to a shortage of new cars caused by plant closures. The paper however, failed to mention the nearly half a million cars currently sitting ideal on Hertz car lots. With practically no one traveling these days, the need for rental cars has evaporated. Hertz (HTZ) and Avis-Budget (CAR) have suffered the most. Hertz has bigger problems than COVID-19 and that is it’s balance sheet.

There are several stories suggesting a Hertz bankruptcy is around the corner.

Hertz is near bankruptcy

According to Bloomberg, Hertz’s situation is a three-way standoff between Holders of Hertz’s asset-backed securities. They could delay pressuring Hertz to sell down its fleet for a short period of time, but they will need Hertz’s banks to promise to make them whole. The banks, in turn, may not want to take on such a risk, which requires them to bet that either the rental car business or used car prices return to some normal operating level.

A 2-year price chart of Hertz (HTZ), Stockwinners

Meanwhile, controlling shareholder Carl Icahn (IEP) holds a 39% equity stake in the rental company. Bloomberg says that he could put in more money to keep Hertz afloat, but this once again is dependent on a belief that the rental car business will recover to some extent in the very near future.

Carl Icahn

In a bankruptcy, Bloomberg notes, equity holders’ claims would be behind those of creditors, which is not an incentive for Icahn to put in more money at the moment.

Used car prices have fallen sharply due to Covid-19

A Hertz bankruptcy could flood the used car market with several hundred thousand cars, whose value is likely to take a substantial hit at a time when used car lots are already quite full and demand is low.

Companies now deliver used cars to your home for test drives

Bloomberg notes that used car prices dropped 11.4% from March to April, while sales were merely a quarter of pre-outbreak levels.

Meanwhile Hertz has started discounting its cars on its used car lots and Hertz Car Sales. In fact, you can pick up a car, and they will deliver it to your house for a test drive. We have seen discounts as high as 25% on some models.  The company carries brands like Ford, Chevrolet, Toyota and Nissan, to some luxury brands like Audi, Jaguar and Mercedes-Benz.

Cars are discounted by Hertz

One more footnote to this story: auto dealerships usually set their used car prices as a function of new car prices. With most of the domestic auto plants closed, price of new cars (2021 model year) will not be known anytime soon.

Companies in the space include: Copart (CPRT), CarMax (KMX), Carvana (CVNA), CarGurus (CARG), Penske (PAG). AutoNation (AN). 

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Chesapeake Energy may file for bankruptcy

Chesapeake Energy slides as company considers bankruptcy, strategic alternatives

Shares of Chesapeake Energy (CHK) are tumbling after the company warned that it might not be able to stay in business amid low commodity prices caused by a global price war and depressed demand due to the COVID-19 pandemic.

Chesapeake is near bankruptcy

EVALUATING STRATEGIC ALTERNATIVES:

On Monday, Chesapeake Energy announced that it filed its Form 10-Q for the three-month period ended March 31, 2020 and, in light of the unprecedented market environment, has withdrawn the financial outlook it previously provided on February 26, 2020.

The company also reinstated a “going concern” warning. “Fluctuations in oil and natural gas prices have a material impact on our financial position, results of operations, cash flows and quantities of oil, natural gas and NGL reserves that may be economically produced.

Historically, oil and natural gas prices have been volatile; however, the volatility in the prices for these commodities has substantially increased as a result of COVID-19 and the OPEC+ decisions […]

Historical oil prices represented in 2020 dollar, Stockwinners

If the current depressed prices persist, combined with the scheduled reductions in the leverage ratio covenant and an expected significant reduction in our borrowing base in our scheduled determination, then our liquidity and our ability to comply with our financial covenants during the next 12 months will be adversely affected,” Chesapeake said in the filing.

Boom to bust for CHK

“Based on our current forecast, we do not expect to be in compliance with our financial covenants beginning in the fourth quarter of 2020. Failure to comply with these covenants, if not waived, would result in an event of default under our revolving credit facility, the potential acceleration of outstanding debt thereunder and the potential foreclosure on the collateral securing such debt, and could cause a cross-default under our other outstanding indebtedness.

As a result of the impacts to the company’s financial position resulting from declining industry conditions and in consideration of the substantial amount of long-term debt outstanding, the company has engaged advisors to assist with the evaluation of strategic alternatives, which may include, but not be limited to, seeking a restructuring, amendment or refinancing of existing debt through a private restructuring or reorganization under Chapter 11 of the Bankruptcy Code.

However, there can be no assurances that the company will be able to successfully restructure its indebtedness, improve its financial position or complete any strategic transactions. As a result of these uncertainties and the likelihood of a restructuring or reorganization, management has concluded that there is substantial doubt about the company’s ability to continue as a going concern.”

REVERSE STOCK SPLITs NEVER WORK:

Chesapeake stock has lost about 50% of it’s value since a 1-for-200 reverse stock split took effect after the close of trading on April 14, 2020.

The company had implemented the reverse split to raise its share price enough to regain compliance with listing standards, but it was viewed as validation of investor concerns as the company struggled with falling commodities prices, high debt levels and the effects of the COVID-19 pandemic, the author added.

The company lost its way after Aubrey McClendon, a founder and former chief executive of Chesapeake Energy, died in a fiery car crash in 2016, a day after he was charged with conspiring to rig bids for oil and natural gas leases. Many believe he committed suicide.

Aubrey McClendon

McClendon — a key player in the U.S. shale boom — co-founded Chesapeake in 1989 and stepped down from the company in 2013. Chesapeake used to be the second-largest natural gas producer in the United States.

PRICE ACTION: In afternoon trading on Tuesday, shares of Chesapeake have dropped almost 22% to $10.13.

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Retail bankruptcy filings are coming

J. Crew files for bankruptcy; Madewell to remain part of J.Crew

J.Crew Group announced it has reached an agreement with its lenders holding approximately 71% of its Term Loan and approximately 78% of its IPCo Notes, as well as with its financial sponsors, under which the Company will restructure its debt and deleverage its balance sheet, positioning J.Crew and Madewell for long-term success.

Madewell to remain part of the J.Crew Company, Stockwinners

Under the terms of the Transaction Support Agreement, the Company’s lenders will convert approximately $1.65 billion of the Company’s debt into equity.

To facilitate the restructuring contemplated by the TSA, the parent company of J.Crew Group, Inc., Chinos Holdings, Inc. and certain affiliates, have filed voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Eastern District of Virginia.

The Company has secured commitments for a debtor-in-possession financing facility of $400 million and committed exit financing provided by existing lenders Anchorage Capital Group, L.L.C., GSO Capital Partners and Davidson Kempner Capital Management LP, among others.

Subject to Court approval, the DIP financing, combined with the Company’s projected cash flows, is expected to support its operations during the restructuring process.

As part of the TSA, Madewell will remain part of J.Crew Group, Inc.

Libby Wadle will continue in her role as CEO of Madewell.

J.Crew files for Chapter 11 bankruptcy protection, Stockwinners

“This agreement with our lenders represents a critical milestone in the ongoing process to transform our business with the goal of driving long-term, sustainable growth for J.Crew and further enhancing Madewell’s growth momentum,” said Jan Singer, CEO, J.Crew Group.

Neiman Marcus is expected to file for bankruptcy protection too

“Throughout this process, we will continue to provide our customers with the exceptional merchandise and service they expect from us, and we will continue all day-to-day operations, albeit under these extraordinary COVID-19-related circumstances.

Pier 1 Imports filed for bankruptcy protection

As we look to reopen our stores as quickly and safely as possible, this comprehensive financial restructuring should enable our business and brands to thrive for years to come.”

GNC is also expected to file for bankruptcy protection

The Company has filed a series of customary “first day” motions with the Bankruptcy Court seeking to maintain its operations during the restructuring process to help facilitate a smooth transition into Chapter 11.

JCP is inline for bankruptcy filing protection following weak sales

Note that in 2011, TPG Capital LP and Leonard Green & Partners LP privatized J.Crew in a $3 billion leveraged buyout.

Recent bankrupt retailers include Forever 21 and Pier 1 Imports.

Forever 21 filed for bankruptcy protection recently

Other retailers that may file for bankruptcy in the near future include: Neiman Marcus, JCP, GNC, and AEO. Note that Gaps (GPS) has been suffering from soft retail sales. Lands’ End (LE) is also suffering from soft sales.

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Amarin shares tumble as court voids patent

Amarin ‘strongly disagrees’ with ruling in Vascepa ANDA litigation

Shares of Amarin (AMRN) tumbled in after hours trading after a federal judge ruled patents on its best selling drug, Vascepa was invalid. The company issued the following statement after shares tumbled 65 percent.

Amarin loses patent on its Vascepa, Stockwinners

Vascepa (Icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. It is used along with a proper diet to help lower fats (triglycerides) in the blood. This medication is thought to work by decreasing the amount of triglycerides made by the body.

Amarin Corporation (AMRN) commented on the United States District Court for the District of Nevada’s ruling in favor of the generic companies in the company’s patent litigation against two filers of abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA capsule franchise.

Vascepa is derived from fish oil, Stockwinners

Based on Amarin’s review of U.S. Food and Drug Administration’s website, an ANDA for VASCEPA has not been approved, which would be required for launch of a generic product in the United States.

The company thus does not believe there is an impending generic launch by the litigants that would compete with VASCEPA at this time.

“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of VASCEPA in the United States,” said John F. Thero, president and chief executive officer of Amarin.

“At Amarin, we have a strong balance sheet with capacity and flexibility, and we plan to fight to protect our VASCEPA franchise for the benefit of our patients, physicians, the broader healthcare community and our investors.

We believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal.

UK’s Hikma Pharma. had asked for overturn of the patent

As we work to take all legal actions necessary to defend and protect our intellectual property, we will continue to press forward with our educational and promotional efforts for VASCEPA in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke. After we determine the outcome of our effort to prevent a generic launch (if an ANDA approval is obtained), we expect to provide an update on how we would adjust certain promotional activities for VASCEPA in the United States.”

Generic drug maker Dr. Reddy’s will be making generic Vascepa

Generic drugmakers Hikma Pharmaceuticals of UK and Dr. Reddy’s Laboratories Limited  (RDY) had asked to overturn the patents so they can begin making generic versions of the medication.

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Mallinckrodt Pays $1.6B into Opioid Trust Fund, Avoids Bankruptcy

North Carolina AG announces $1.6B opioid settlement with Mallinckrodt

North Carolina Attorney General Josh Stein announced a global settlement framework agreement between state attorneys general, local subdivisions, and the opioid manufacturer Mallinckrodt (MNK), its subsidiaries, and certain other affiliates.

MNK is currently the largest generic opioid manufacturer in the United States.

MNK pays $1.6B to avoid bankruptcy, Stockwinners

In the agreement, MNK agrees to pay $1.6B in cash to a trust that will cover the costs of opioid addiction treatment and related efforts, with the potential for increased payment to the trust.

The agreement in principle has been reached with a court-appointed plaintiffs’ executive committee representing the interests of thousands of plaintiffs in the opioid multidistrict litigation, and is supported by a broad-based group of 47 state and U.S. Territory Attorneys General.

Under the terms of the proposed settlement, which would become effective upon Specialty Generics’ emergence from a contemplated Chapter 11 process, subject to court approval and other conditions: Plaintiffs would receive $1.6B in structured payments, of which $300M would be received upon Specialty Generics’ emergence from the completed Chapter 11 case, $200M would be received on each of the first and second anniversaries of emergence, and $150M would be received on each of the third through eighth anniversaries of emergence.

The substantial majority of those payments are expected to be contributed to a trust which, among other things, would establish an abatement fund to be administered to cover the costs of opioid-addiction treatment and related efforts.

Upon Specialty Generics’ emergence from the contemplated Chapter 11 process, the trust would receive warrants, exercisable at $3.15 per share, to purchase ordinary shares that would represent approximately 19.99% of the company’s fully diluted outstanding shares, including after giving effect to the exercise of the warrants.

To implement the proposed settlement, the company expects that Specialty Generics, which manufactures certain generic opioid products, among other products, will file voluntary petitions under Chapter 11 of the U.S. Bankruptcy Code in the coming months.

Mallinckrodt and its Specialty Brands-related subsidiaries would not be part of the Chapter 11 filing.

This court-supervised process is expected to lead to the creation of a trust which, among other things, would establish an abatement fund to offset the expense of helping to combat opioid addiction and providing support to communities impacted by opioid abuse.

The court-supervised process is also expected to provide a fair, orderly, efficient and legally binding mechanism to resolve all opioid-related claims against the company, Specialty Generics, and all of Mallinckrodt’s other subsidiaries and related entities. It is expected that Mallinckrodt plc would receive the benefit of a “channeling injunction” that would provide for the release of all opioid-related claims that have been or could have been asserted against Mallinckrodt or its subsidiaries related to Specialty Generics’ manufacture and sale of opioids prior to the time the Specialty Generics Chapter 11 plan becomes effective.

MNK also agrees that its future generic opioid business will be subject to stringent injunctive relief that, among other things, will prevent marketing and ensure systems are in place to prevent drug misuse.

“Confronting the opioid epidemic has been my top priority as North Carolina’s Attorney General,” said Attorney General Josh Stein. “Families all across our state have been torn apart as far too many of our relatives, friends, and neighbors have become sick with addiction and died. The companies that helped to create and fuel this deadly crisis must help us recover. That is exactly why I led negotiations with Mallinckrodt and fought to bring these needed funds home to North Carolina where they will help people get well.”

MNK is up 63 cents to $4.80.

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Aveo Pharma. shares tumble following FDA meeting

Aveo Pharmaceuticals provides update after FDA meeting discussing TIVO-3 results

Aveo Pharmaceuticals (AVEO) provided a regulatory update following a meeting with the FDA to discuss results from the August overall survival, or OS, analysis of the TIVO-3 trial and the company’s proposal to proceed with a new drug application, or NDA, for tivozanib. TIVO-3 is the company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, or VEGFR-TKI, to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma, or RCC.

AVEO shares tumble following FDA meeting, Stockwinners

The TIVO-3 trial was designed to address the FDA’s concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the company’s initial RCC pivotal trial, the FDA found that the inconsistent progression free survival, or PFS, and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.

The company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate.

The August analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio, or HR, of 0.99 at two years from the last patient enrolled in the study.

In the FDA’s preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the company not submit an NDA at this time.

The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the company’s current interim OS results do not abrogate the FDA’s concerns over detriment and that those results may worsen with final analysis at 263 events and that the median OS for tivozanib is worse than that of sorafenib.

In view of the changing first-line treatment landscape as well as the FDA’s continued concerns, the company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC.

At the meeting, the FDA acknowledged AVEO’s responses and reiterated its concerns about the survival information and the totality of data.

The FDA noted that the choice to submit the data is the company’s, and that a discussion with the Oncologic Drug Advisory Committee will likely be required.

The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan, or SAP, with a planned OS update based on the projected number of events at that time.

AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in Q1 of 2020.

AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA.

The FDA and the company agreed that if the final analysis yields an OS HR above 1.00, the company will withdraw its NDA application.

AVEO shares are down 35% to $0.59.

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SmileDirectClub shares tumble on new California law

SmileDirectClub says nothing in AB1519 requires ceasing or modify operations

SmileDirectClub (SDC) issued a statement on California Assembly Bill 1519, stating in part:

“We are pleased with the Governor’s signing statement for AB1519.

New California law sends shares lower, Stockwinners

While the authorizing nature of AB1519 made it difficult to veto the bill, the Governor clearly indicated that he expects all stakeholders to come to together to find a better way to create policy around teledentistry.

While this bill does not preclude SmileDirectClub’s continued operations in California, it will create unnecessary hurdles and costs to Californians that need care but struggle to afford it. The undebated, clinically unsupported, and ill-advised policy changes that are included in this bill – a bill that was intended to reauthorize the Dental Board of California until last-minute policy additions were added – have created arbitrary barriers to technological innovation…Simply put, this bill represents the dental lobby’s thinly-veiled attempt to protect traditional dentistry at the expense of Californians, and Governor Newsom made the correct choice in issuing his strongly-worded rebuke of the tactics and policy that this bill represents.

California law may require a dentist at every SDC shop, Stockwinners

Nothing in AB1519 requires SmileDirectClub to cease or modify its operations, and nothing regarding teledentistry in this legislation can take effect until the Board has given all stakeholders the opportunity to submit public comment and debate the merits of any proposed rules with clinically-based data – as the Governor has requested in his signing statement. To that effect, SmileDirectClub will be reaching out to our partners in the field to coordinate efforts so that a positive outcome for the industry – and for the California consumers – can be reached…To be clear, SmileDirectClub will continue to legally operate in California, we will be an active participant in the administration-directed public debates surrounding teledentistry, and we will continue to provide affordable orthodontic care to thousands of smiling Californians.

Moving forward, SmileDirectClub welcomes transparent policy debates that include all stakeholders.”

Heavy lobbying by both sides made AB-1519 national news, Stockwinners

UBS Comments

UBS analyst Kevin Caliendo noted that California Governor Gavin Newsom signed bill AB-1519 over the weekend and the law is expected to go into effect on January 1, 2020.

He thinks that SmileDirectClub may need to place dentists inside its shops due to the new law, though it is less clear if the bill will mean that patients will need to get x-rays as well as iTero scans, which may eventually be determined in court.

The analyst, who noted that SmileDirect is scheduled to report Q3 results on November 12, noted that he has received questions on if the company might pre-announce, but he has “no insight or precedent into whether the company will opt to do that or not.” Caliendo has a Buy rating and $24 price target on SmileDirectClub shares.

SDC shares are down 9% to $10.12 in Monday’s trading.

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Zogenix tumbles on FDA action

Zogenix gets refusal to file letter from FDA on Fintepla NDA


Zogenix gets refusal to file letter from FDA on Fintepla NDA , Stockwinners

Zogenix (ZGNX) announced that it received a Refusal to File, RTF, letter from the U.S. Food and Drug Administration regarding its New Drug Application for FINTEPLA, for the treatment of seizures associated with Dravet syndrome.

Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), it affects 1:15,700 individuals, 80% of whom have a mutation in their SCN1A gene.

Upon its preliminary review, the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review.

In the letter, the FDA cited two reasons for the RTF decision: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA.

The FDA has not requested or recommended additional clinical efficacy or safety studies.

The company will seek immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.

“We remain highly confident in FINTEPLA’s clinical profile demonstrated in the Phase 3 program in Dravet syndrome and are committed to advancing the product candidate as a potential new treatment option for this and other rare and often catastrophic epileptic encephalopathies,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.

“We are fully committed to working with the FDA as quickly as possible to address the open issues and clarify the path to successfully re-filing our application.”

Zogenix’s Marketing Authorization Application, MAA, for FINTEPLA for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency, EMA, and the Company anticipates an approvability decision could be reached by the EMA in the first quarter of 2020.

Piper Jaffray

Piper Jaffray analyst Danielle Brill lowered her price target on Zogenix to $68 after it received a refusal to file letter from FDA on its Fintepla new drug application.

The analyst notes that while the issues mentioned by the FDA sound like a simple fix, if the agency requires the company to conduct new toxicity studies, the re-submission could be delayed another 12-15 months.

In spite of the “discouraging news”, longer term, Brill still keeps her Overweight rating on Zogenix and believes that “the company should be able to leverage existing ICH data with fenfluramine” based on their reported prior FDA interactions, modeling a launch in Q2 of 2020.

ZGNX closed at $51.85, it last traded at $35.00.

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