Simply unbelievable. This time last year, MNK was worth $2 billion more than it is today AND they have made $800+ million since that time. $2.8 billion less value on absolutely nothing but shorts repeating the same set of lies over and over.
Mallinckrodt Presents Facts to Refute Short-Seller Claims
May 19, 2017
Recent media reports have cited allegations by self-acknowledged short sellers whose thesis on Mallinckrodt, the company believes, is not based on fact and is intentionally misleading. This statement serves to present facts and correct inaccuracies in those media reports.
Mallinckrodt does not publicly disclose profitability of the individual products in its diversified portfolio. Inflated assertions regarding H.P. Acthar® Gel’s contribution to the company’s overall profitability are incorrect. The drug contributes significantly to the company’s profitability, but at a substantially lower level of operating profitability than the 100% erroneously asserted by short seller claims. The suggestion that there is and will be no operating income contribution from other company products is patently untrue.
Allegations that Mallinckrodt carries $8 billion in debt are incorrect. As disclosed in Mallinckrodt’s most recent quarterly report from March 31, 2017, the company’s debt was approximately $6 billion and Mallinckrodt’s debt, net of cash, was $5.8 billion.
In fiscal 2016, Mallinckrodt had $617 million in GAAP operating income and non-GAAP adjusted operating income (OI) of more than $1.4 billion. While Mallinckrodt has not commented on or issued guidance related to OI for 2017, current consensus OI estimates for the company are well in excess of $1 billion on a non-GAAP basis. Speculation that Mallinckrodt’s annualized OI for 2017 will be $300 million based on results from the most recent quarter is erroneous.
H.P. Acthar Gel’s efficacy in its approved indications is strongly supported by evidence. The U.S. Food and Drug Administration (FDA) reviewed the label in 2010, and determined there in fact was sufficient scientific and clinical evidence to support the 19 indications now in the current label. The drug makes a significant difference in the lives of thousands of very sick patients with high unmet medical needs. Mallinckrodt prices its products responsibly, and in a way that reflects the value they offer patients, providers and the U.S. healthcare system as a whole.
Since acquiring H.P. Acthar Gel in 2014, Mallinckrodt has invested more than a quarter of a billion dollars into the drug, including building a larger body of evidence for the drug through clinical trials and health economic outcomes research data; payer engagement; manufacturing modernization; and other medical affairs and research activities.
MNK-1411 (formerly Synacthen® Depot) is simply not a “generic competitor to Acthar” – the two products are very different drugs. MNK-1411 is not approved by the FDA for any indications, and has never been commercialized in the United States. H.P. Acthar Gel is a biologically derived, 39-peptide chain that includes more than simply ACTH, while MNK-1411 is a synthetic 24-peptide chain. Importantly, the company believes the regulatory path for any corticotropin-type new drug application would require FDA approval and could take many years if successful.
In the commercial reimbursement space, the majority of payers have an established pathway for the use of H.P. Acthar Gel in those patients for whom it is appropriately prescribed – those with conditions covered by the FDA-approved label and for whom the product’s extensive existing data and clinical experience support H.P. Acthar Gel’s use as a proven therapy. The prior-authorization and reimbursement processes used by commercial payers rely on these criteria, and are not bypassed through co-pay programs.
Mallinckrodt has arms-length contracts for services with subsidiaries of Express Scripts for product distribution to a network of several independent, individually contracted specialty pharmacies, and separately for order processing. A separate subsidiary of Express Scripts, United BioSource Corporation, also manages a patient assistance program which provides free product to low-income, uninsured or underinsured patients who qualify. Utilization of all these services is a standard industry practice for most specialty pharmaceutical drugs, of which H.P. Acthar Gel is one.
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
As an orphan monotherapy medication for the treatment of IS in infants and children under 2 years of age.
Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
Treatment of acute exacerbations of multiple sclerosis in adults.
Use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
Use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).
Use as adjunct therapy for short-term administration in select cases of rheumatoid arthritis, to tide patients over an acute episode or exacerbation.
Treatment of symptomatic sarcoidosis.
RALLLLLLLLLYYYYYYYYYYYY ..Its like buying JAZZ at $1 a few years ago (AXSM) Market Cap $90 M/Cash $55 M / 5x BIG Phase 3 programs in various indications targeting large Markets with first results in Q3 2017 =20 BAGGER ..FANTASTIC OPPORTUNITY !
Undiscovered and massive undervalued Biotech Stock with lots of Big News on the way.This Stock is brutally undervalued with a Market cap of just $90 million and $55 million in cash .Founder and Ceo is the larget shareholder holding over 7 million shares (30%) more than 50% of O/S is owned by Insider and Institutions which is a great sign .
This undiscovered stock could be the next 10 bagger gem if just one of their 5 ongoing Phase 3 programs is successful .GL
Market-Cap: $90 Million Cash: $55 Million(cash runway into the first quarter of 2019.) Price:$3.90
Shares Out: 23.5 Million
Anticipated Near-Term Clinical Milestones
Clinical Trial Initiations: -- Phase 2/3 clinical trial of AXS-05 in AD agitation (2Q 2017)
Clinical Trial Readouts:
-- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (3Q 2017)
-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (4Q 2017)
-- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1Q 2018)
AXS-05 Treatment Resistant Depression in Phase 3......Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.
AXS-05 Agitation in Alzheimer’s Disease in Phase 2/3.......No approved medication = unmet medical need. 2M patients in the U.S.
AXS-02 Complex Regional Pain Syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status).......No approved drug = high unmet need. 80,000 new cases per year in the U.S.
AXS-02 Knee Osteoarthritis (OA) with Bone Marrow Lesions (BMLs) in Phase 3 (SPA & Fast Track).........7M patients in the U.S.
AXS-02 Chronic Low Back Pain(CLBP) with Modic Changes (MCs) in Phase 3 ......1.6M patients in the U.S.
“MNK-1411, formerly Synacthen Depot, is not a ‘generic competitor to Acthar.’ They are two very different drugs. Acthar is a biologically derived, 39-peptide chain that includes more than simply ACTH, while MNK-1411 is a synthetic 24-peptide chain. Mallinckrodt believes the regulatory path for any corticotropin-type new drug application would require FDA approval, which could take years.”
(MNK-1411 is the drug now licensed to Marathon Pharmaceuticals.)
Brian Henry, spokesman for Express Scripts, said the firm found Chanos' presentation "wildly inaccurate." .... Express Script's Henry said his company's patient assistance program for Mallinckrodt's Acthar Gel "has no payer impact." He said in a statement that the Acthar Gel patient assistance program managed by United BioSource Corporation (UBC) means that underinsured or uninsured patients who meet clinical requirements for Acthar Gel receive the drug free of charge.
"There is no payer impact because the cost of the drug is paid fully by the manufacturer," he said. "This program is not like a manufacturer co-pay card program. UBC does not bill payers. We do not circumvent payer prior authorization rules or reimbursement." Henry also said the Acthar Gel PAP (patient assistance program) is a free goods program.
Shares cannot stay at this level. MNK can and will buy back half the shares outstanding before ANI's cortico even reaches the market. At that point EPS would be $15-16 a share with no growth in net income. Even if ANI was able to reduce Acthar by 20% per year thereafter, which is far more than even ANI predicts or wants, MNK could boost earnings 20-30% per year with just buybacks. IF ANI's cortico is rejected, which is the most likely outcome, MNK goes to $100+ a share easily.
So Chanos comes out day before options exp. with his drivel and talk of shorting it like hell. Probably already covered. Only criminals in the house is Chanos.
Yet another lie told by Jim Chanos on Bloomberg: taxpayers are paying the majority of the bill for this drug. Wrong.
I can't wait to see the new short interest. I'm really hoping we can get to 25 million shares. Despite the rhetoric, shorts are actually pretty light on MNK compared to many other specialty pharmas.
Everyone please welcome our newest idiot short seller, Jim Chanos, who announced his short position at the SALT conference. That's what sent MNK diving momentarily as his lemmings piled on. Jim is short MNK and ESRX because the two have a "murky alliance." What a thesis!
Cover my short positions yesterday. Mnk should make at least 800 million this year. They should pay down debt , instead of buying back shares.
Jim Chanos: Well, there's $8 billion in debt here, and the operating income (most recent quarter annualized) is under $300 million.
Annualize the most recent quarter, who would do that?
at 41 support( lowest stock has ever been back in 2014) loaded 1,000 shares
jim is spinning good I see says 8B debt , when it is 6 uses 300m operating income when in fact cashflow is close to $1B says stock is worth zero - that is laughable sorry jimbo - not buying your bs
Why does the P/E ratio always say negative or some ridiculous number. It's selling at like a 7.
Chano was dea wrong on NVDA n got burned
Marathon Pharma a small 100 employee company is solely permitted to develop generic anthar. It would take a decade and 100 mill dollars. The insurance companies would not approve it because of terrible side effects. Its economically unfeasible.
Amazing. Trump's big mouth about drug companies crushed them last fall and this spring. He and his agenda are finished. Mike pence isn't going to do anything to drug companies. Drug stocks still get slammed. Heads we win, tails you lose. On the bright side, MNK will continue to buy back shares, only they'll get even more for their money.
four years ago stock was this price altho eps was half what it is now. Please check to see what happened in the subsequent year with the stock price. Also consider buyback this yr if equal to last yr will have huge pos effect on eps. short this it will be fun and so rewarding.
"I can say that in 10 years we can pretty much count on Acthar being replaced by generics or negotiated down." - Jim Chanos
Wow awesome rebound! Lol... Keep buying those dips boys!