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Fully vested by 10/19/19, 4 yrs minus 1 month, $2.41/sh strike price, sweet price!

an interview this week, Edstrom said the company has put a lot of money into a market research project with a consultant that discussed Mannkind’s technology with physicians, experts and researchers and looked at an inventory of unmet medical needs.

The company is in the process of reviewing where their technology could be beneficial, Edstrom said. The technology could potentially be used with drugs that are toxic to the liver, because Mannkind’s system bypasses the organ; drugs used for pain, pulmonary-related diseases and central nervous system diseases [Could be MS Copaxone generic] ; and for smoking cessation, he said.

“We’re trying to build a portfolio of probably about four to six products that we will pursue,” Edstrom said. “Not all of them will be successful, but you’ve got to start and then hope that you reach all the way through regulatory approval to the market.”
m.newstimes.com/business/article/Danbury-based-Mannkind-to-unveil-new-product-6427414.php

Definition of Multiple Sclerosis:

A disorder of the brain and spinal cord (central nervous system) caused by progressive damage to the outer covering of nerve cells (myelin). This results in decreased nerve functioning which can lead to a variety of symptoms.

MannKind CEO Hakan Edstrom leaves – Unsung departure

(management-change.com) – Valencia, California, November 20, 2015 – It is an unsung departure. Hakan Edstrom (65), chief executive of MannKind Corporation, leaves. It is an abrupt change. As announced by MannKind in a news release on Friday, November 20, 2015, Hakan S. Edstrom has already left the post as Chief Executive Officer at the biopharmaceutical company in a surprising move after less than one year on the job on November 19, 2015.

The search for a successor is underway.


His duties will be taken over on an interim basis by Al Mann (89), founder and Executive Chairman of MannKind.

Share price decline

The change follows a sharp decline in the share price of MannKind Corporation since June 2014.

Bumpy period

The shake-up comes amid a bumpy period for the business. MannKind develops an inhaled insulin drug, which it began selling in February under a partnership with Sanofi. But sales of the drug have been much lower than expected.

No reason given

In the announcement, MannKind did not explain the reason for the sudden management change.

Seldom a good sign

It is seldom a good sign when a top manager leaves the position at short notice and without an understandable explanation. “Hakan Edstrom has stepped down as the President, Chief Executive Officer and as a director of MannKind,” MannKind only said.

Information about the future plans of Edstrom was not immediately available.

Hakan S. Edstrom has been MannKind’s President since April 2001 and has served as one of MannKind’s directors since December 2001. From April 2001 until January 2015, Edstrom was MannKind’s Chief Operating Officer. In January 2015 he became MannKind’s Chief Executive Officer.

Bausch & Lomb, Pharmacia

Edstrom was with Bausch & Lomb, Inc., a health care product company, from January 1998 to April 2001, advancing to the position of Senior Corporate Vice President and President of Bausch & Lomb, Inc. Americas Region.

From 1981 to 1997, Edstrom was with Pharmacia Corporation, where he held various executive positions, including President and Chief Executive Officer of Pharmacia Ophthalmics Inc.

Alarm signal

When a top manager steps aside with no permanent successor in place, it is always an alarm signal. It may be a sign that the outgoing manager has been asked to leave or threw in the towel. It can also indicate a dispute.

Next best solution

It’s best practice for a board to have a pipeline in place for top leadership. Making the chairman interim Chief Executive Officer is the next best solution.

Search for a successor

A committee of the board will commence an immediate search for a successor CEO, MannKind said.

Al Mann takes over

The duties of Edstrom are taken over by Alfred (Al) Mann as interim Chief Executive Officer, effective on November 19, 2015. Alfred E. Mann founded Mannkind Corp., and has been its Executive Chairman since January 2015. Mann will continue to serve as the Executive Chairman of the Company.

Unsung departure

Taking as a basis the announcement from Valencia, California-based MannKind, it is an unsung departure for Edstrom.

In the very formal statement which consists only of four sentences, the departing chief executive gets no words of praise for concrete successes, no word of appreciation, no explicit word of thanks, no word of regret and no good wishes. It remains unclear whether the initiative for the change came from Edstrom. It is not clear why the 65-year-old Edstrom leaves the post so suddenly.

Terms of the management change were not immediately disclosed.

The switch happened so quickly that MannKind Corporation still lists Edstrom as director on its leadership page.

No personal words

Personal words for Edstrom from the management were not contained in the statement.

Salary details for Mann were not immediately disclosed.

No remarks from Edstrom

In the brief announcement from MannKind, Edstrom gets no chance to speak.

MannKind: $1 billion market value

MannKind is listed at Nasdaq and has a market capitalization of about $1 billion.

management-change.com publishes reports on capital market-relevant management changes, with special focus on facts, figures and form.
management-change.com/mannkind-ceo-hakan-edstrom-leaves-unsung-departure/

1.25 “Commercially Reasonable Efforts” shall mean:
(a) With respect to efforts of Sanofi as measured on a country by country basis: that measure of efforts and resources consistent with Sanofi’s and its Affiliates’ own efforts and resources applied to its and their own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential, taking into account all relevant factors including issues of safety and efficacy, product profile, difficulty in developing or manufacturing the applicable Product or sourcing raw materials necessary therefor, competitiveness of alternative third party products in the marketplace, regulatory approvals (including pricing approvals), pricing and reimbursement, the patent or other proprietary position of the applicable Product, the regulatory requirements involved and the potential profitability of the applicable Product for Sanofi and its Affiliates as compared to the expected profitability of other products of its then current or in development product portfolios; and
www.sec.gov/Archives/edgar/data/899460/000119312514406347/d783199dex101.htm
It's not reasonable effort until some months after international launch.

12.2 Termination by the Parties.
(a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, if Sanofi is the Breaching Party and the breach is with respect to Sanofi’s failure to comply with its obligation to use Commercially Reasonable Efforts with respect to (x) the United States, MannKind may terminate this Agreement in its entirety, and (y) any Major Market (other than the United States) or […***…] Country, MannKind may terminate this Agreement only with respect to such Major Market or […***…] Country (as applicable) and not in its entirety. If the Breaching Party disputes in good faith that it has materially breached one of

***Confidential Treatment Requested
51.
CONFIDENTIAL

its obligations under this Agreement, termination shall not take effect pending resolution of such dispute pursuant to Article 14. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of one or more of its obligations under this Agreement (an “Adverse Ruling”), then if the Breaching Party fails to complete the actions specified by the Adverse Ruling to cure such breach within ninety (90) days (or forty five (45) days for any payment breach) after such Adverse Ruling, then the Complaining Party may terminate this Agreement upon written notice to the Breaching Party.
(b) Termination Upon Insolvency. Either Party will be entitled to terminate this Agreement with immediate effect by notice in writing if the other Party files for protection under bankruptcy or insolvency laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver, administrator, manager, trustee or like official over its property that is not discharged within 90 days, proposes a written agreement of composition or extension of its debts, is a party to any dissolution, winding-up or liquidation or has any such petition filed against it which involuntary petition is not discharged within 60 days of the filing thereof.
12.3 Additional Sanofi Termination Rights.
(a) If, at any time on or after January 1, 2016, Sanofi determines in good faith that Commercialization of Product is no longer economically viable in the United States, then Sanofi may terminate this Agreement in its entirety upon delivery of at least ninety (90) days’ prior written notice to MannKind. In addition, at any time on or after January 1, 2016, upon delivery of at least six (6) months’ prior written notice to MannKind, Sanofi shall have the right to terminate this Agreement for any reason (a) in its entirety, or (b) on a country-by-country basis other than with respect to the United States; provided, however, that if Sanofi terminates this Agreement under this Section 12.3(a) in each of […***…], then Sanofi shall terminate this Agreement with respect to all countries of the European Union. For purposes of clarity, Sanofi shall have no right to terminate this Agreement with respect to only the United States under this Section 12.3(a).
(b) Termination for Safety or Regulatory Reasons. On a country-by-country basis, Sanofi shall have the right in its sole discretion to terminate this Agreement in such country immediately upon thirty (30) days’ written notice to MannKind in the event:
(i) of withdrawal or indefinite suspension of any MAA for a Product in such country; or
(ii) that Sanofi determines in good faith that pursuing the Development or Commercialization of a Product in the Territory or any part thereof poses an unacceptable medical risk to patients.
12.4 Additional MannKind Termination Right. MannKind shall have the right to terminate this Agreement immediately upon written notice to Sanofi if Sanofi or any of its Affiliates or sublicensees directly, or indirectly through any Third Party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of,

***Confidential Treatment Requested
52.
CONFIDENTIAL

or opposes any extension of or the grant of a supplementary protection certificate with respect to, any MannKind Patent; provided that MannKind shall not have such right to terminate this Agreement for a proceeding, challenge or opposition of the type described above (in each case, a “Challenge”) by a sublicensee if (a) the sublicense agreement with such sublicensee includes a right of the applicable sublicensor (Sanofi, its Affiliate or another sublicensee, as applicable) to terminate the sublicense following written notice to such sublicensee and, if applicable, a cure period not to exceed sixty (60) days if such sublicensee directly, or indirectly through any Third Party, institutes a Challenge of any MannKind Patent and (b) either (i) the applicable sublicensor diligently enforces its rights to cause the sublicensee to withdraw or dismiss such Challenge including, if applicable, exercise of such termination right promptly following the expiration of any applicable cure period or (ii) such Challenge is withdrawn or dismissed within thirty (30) days after a request by the applicable sublicensor or by MannKind to do.
12.5 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies will remain available except as agreed to otherwise herein. Notwithstanding the foregoing, termination of this Agreement in the applicable […***…] Country in accordance with Section 12.2(a) shall be MannKind’s sole remedy for Sanofi’s failure to comply with its obligations under Section 4.2(c) to use Commercially Reasonable Efforts to file for, obtain or maintain Marketing Approvals for Product in the Field in any […***…] Country.

Amy T said,
When I met with Sanofi execs, I was able to ask them directly, and was told there’ve been three barriers to Afrezza’s success so far:

Physicians haven’t heard about inhalable insulin for several years (and lingering memories of the Exubera fiasco don’t help)

The requirement for a pulmonary function test is a deterrent – doctors have to figure out where to refer patients for this, or decided to fork over the roughly $600 to get their own machine

Reimbursement is a struggle, as Medicare and the other Payors already have one or more preferred rapid-acting insulin products on their formularies, so Afrezza is getting bumped to a lower tier (meaning not covered so much)

Sanofi does plan to begin a consumer advertising campaign towards the end of this year that will focus on digital and print, but no TV ads, according to Andrew Purcell, Head of the Diabetes Business Unit at Sanofi. They’re hoping to “demonstrate success” with the drug first.
www.healthline.com/diabetesmine/overview-ada-scientific-sessions-2015
We need to apply for MAA ASAP after the 2 study results are posted to FDA. Chances are we will get the superior label for international expansion.

If we launch in 12 countries, and each country hits $21M annual rev, we will get $250M sale bonus much more easily. It's a bootstrap process from there on out.

One of major disconnects between Sny and us is they have time to be deliberate and methodical while we don't unless ...