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Post by lakers on May 9, 2016 18:21:54 GMT -5
Well, for whomever wished to have BK off the table for the rest of the year - here you go. You can certainly include me in that group. Dilution always better than BK. I just listened to CC and replayed the two sections dealing with financing multiple times. Not really sure why Matt couldn't discuss the offering but he was clearly very very uncomfortable. It sounds like he was waiting for as long as possible for an international deal to come through but, like he said, he couldn't wait forever. The fact that they were able to get the financing deal done is encouraging on two fronts, I think. One, the company definitely does need the cash. Two, Matt must have been able to convince the institutions that are buying the 50 million shares that a deal (or more) is imminent. Otherwise, why would anyone be willing to buy those shares (and warrants) no matter how low the price. So, all in all, I think you're right, BK is off the table for the rest of the year. Also important to keep in mind that dilution is hardly onerous. And, to repeat, much much better than running out of cash. Very perceptible. $1.5 Warrant A exercisable immediately. Cash in hand strengthens international partnership and settlement negotiation. More to come ...5/12 is BofA. 5/19 is ASH.
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Post by lakers on May 6, 2016 17:03:37 GMT -5
SNY settlement may come first. Matt will explain the funding source for those new hires and open reqs.
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Post by lakers on Apr 18, 2016 19:39:01 GMT -5
Amphastar at 15th Annual Needham Healthcare Conference April 13, 2016, SLide 5/20 Recombinant Human Insulin (RHI) − RHI from AFP is used in our pipeline − 2014 supply agreement with MannKind to supply RHI for Afrezza® − Agreement specifies minimum annual sales of 24 million euros annually for 5 years from 2015 - 2019 − Further amounts may be purchased − 2015 Option Agreement to supply additional quantities in 2016-2019 − If MannKind chooses not to exercise its option, they pay a cancelation fee − Bankruptcy would terminate contract − Several other customers currently purchasing R&D quantities for filings outside of the US − One customer buying production quantities outside of the US − MannKind purchased $20 million in 2015− Mutually agreed to take a lower quantity than contractually required in 2015ir.amphastar.com/events.cfm
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Post by lakers on Apr 13, 2016 1:17:03 GMT -5
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Post by lakers on Apr 12, 2016 20:01:19 GMT -5
0010 Post Date 4/12/2016 Title Regional Business Director City Valencia State CA Description MannKind Corporation is currently seeking an East and West Coast Regional Business Director. In this position the incumbent will be responsible for the implementation of the strategic initiatives developed by the CCO and Executive Leadership Team. The Regional Business Director (RBD) will serve as the key sales leader in his or her assigned area. Responsibilities will include planning, organizing and directing sales activities and strategies to ensure effective, compliant promotion of Afrezza to physicians and other health care providers. The RBD will also manage projects involving cross-functional communication and activities. The RBD will lead and manage the Regional Sales Managers (RSM). Work with CCO, other Regional Business Director and Senior Management in organizing MannKind long-term sales objectives, sales force requirements and establishing solutions that optimize sales effort. Participate in and implement national strategies by driving ideas and tactics to manage opportunities and challenges. Ensure the development of Regional strategies that embody the same elements. Set clear and consistent performance expectations with RSMs. Provide managerial excellence in recruiting and developing a high performance team. Ensure region meets and/or exceeds sales goals and targets. Identify and cultivate appropriate business relationships with key opinion leaders. Develop the leadership and management skill sets of RSMs. Work with individuals to create action plans for continued development and progression; provide first-line guidance to team members for their personal and career development. Responsible for local/regional payor relationships and pull through of formulary access. Set and monitor divisional operating and expense budgets to ensure compliance and optimal use of resources. Track, monitor and report on sales performance and progress. Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Requirements BA/BS Degree required Master’s Degree preferred 12 years of experience, preferably with at least 8 or more years in the pharmaceutical industry Must have supervisory experience in a sales or sales-related function Experience in the oversight and leadership of managers who manage field-based teams is preferred Exceptional KOL development Strong analytical skills Proven track record of sales success Travel required rew12.ultipro.com/MAN1011/JobBoard/JobDetails.aspx?__ID=*6A3B85AF5A256C48
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Post by lakers on Apr 11, 2016 17:47:10 GMT -5
MannKind's Chief Executive Officer, Matthew J. Pfeffer, and Chief Commercial Officer, Michael E. Castagna, will discuss the
strategic commercial approach for Afrezza in the U.S. The discussion will include plans for sales and marketing of Afrezza,
including reimbursement and access programs for patients, marketing programs and expansion plans. Timelines for
relaunch activities will also be discussed.
I expect expansion plans to include Canada, Israel first. This may entail signing up regional partners. This may get the St. excited and shorts nervous.
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Post by lakers on Apr 9, 2016 21:00:02 GMT -5
Success of Continuing Medical Education on Appropriate Clinical Use of Inhaled Insulin Therapy Program: Abstracts - Orals, Poster Previews, and Posters Session: SUN 756-770-Endocrine Healthcare Delivery and Education (posters) Clinical Sunday, April 3, 2016: 1:15 PM-3:15 PM Exhibit/Poster Hall (BCEC) Poster Board SUN 759 Amy Larkin1, Michael LaCouture*2 and Anne Le1 1Medscape Education, 2Medscape Education, Mount Laurel, NJ Introduction Postprandial hyperglycemia in both type 1 and type 2 diabetes is difficult to control, as traditional forms of rapid-acting insulin are unable to replicate the sharp insulin spike experienced after a meal by healthy individuals. We sought to determine if participating in a series of educational interventions related to the clinical use of a new rapid-acting insulin formulation could improve the knowledge, competence, and clinical decision-making of primary care physicians (PCPs) and diabetologists/endocrinologists (diab/endos) in the United States (US). bit.ly/1VFOV4mMethods PCPs and diab/endos participated in at least 1 of 3 online CME activities within a curriculum on clinical use of inhaled insulin. Activities launched online between April and June, 2015, and data were collected through June (for posting dates in April) or September (for posting dates in June), 2015. The effects of education were assessed using knowledge- and case-based matched pre- and post-assessments. McNemar’s chi-squared test was used to assess whether the mean post-assessment score differed from the mean pre-assessment score; P values <.05 are statistically significant. Major Results Improved knowledge, competence, and clinical-decision making was seen among PCPs (n = 2040; P <.05 all activities) and diab/endos (n = 815; P <.05 all activities). Significant changes were seen in the following areas (all P < .05): 37% increase by PCPs and 40% increase by diab/endos in recognizing the mechanism of action of inhaled insulin 30% increase by PCPs and 19% increase by diab/endos in differentiating inhaled insulin and other forms of rapid acting insulin 33% increase by PCPs (and 34% increase by diab/endos understanding how modern inhaled insulin differs from older inhaled insulin formulations 20% increase by PCPs and 19% increase by diab/endos in making correct clinical decisions about the clinical use of inhaled insulin 35% increase by PCPs and 31% increase by diab/endos in selecting strategies to improve patient adherence Areas identified as needing additional education include: 31% of PCPs and 41% of diab/endos remain unclear on strategies for engaging the patient in their care plan 33% of PCPs and 32% of diab/endos remain unclear on efficacy of modern inhaled insulin 22% of PCPs and 24% of diab/endos remain unclear on safety profile of modern inhaled insulin Conclusions This study demonstrates the success of a targeted educational intervention with multiple educational components in multiple formats on improving knowledge, competence, and clinical decision-making of PCPs and diab/endos regarding a new rapid-acting insulin formulation.
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Post by lakers on Apr 9, 2016 1:58:24 GMT -5
Pfizer dropped Exubera on Oct 18, 2017, settled with Nektar on Nov 12, 2017, nearly a month later. www.wsj.com/articles/SB119269071993163273www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlementPfizer said on the call with analysts yesterday that Exubera struggled because patients were resistant to beginning insulin therapy early in their disease, and were reluctant to visit the doctor for the lung-function tests required by regulators. Still, Pfizer promoted the drug until the bitter end. In July, the company rolled out slick television commercials with the catch line "Now I get it," to get patients comfortable with the inhaler. Earlier this week, Exubera was introduced in Canada. In 1998, Pfizer teamed with German company Hoechst Marion Roussel AG to make the insulin, and pledged to build a Frankfurt plant that would employ 200 people. Pfizer declined to say how much it spent on the Frankfurt facility and another in Terre Haute, Ind., but told investors yesterday that it would write off $454 million in fixed assets and $661 million in inventory. The charges sent its third-quarter profit down 77% to $761 million, or 11 cents a share, on revenue of $11.99 billion. Paris-based Sanofi-Aventis ultimately bought the German company and assumed its relationship with Pfizer, and the two companies presented Exubera to the U.S. Food and Drug Administration in 2005. At a meeting with analysts the following year, Ms. Katen told investors that their average forecast for Exubera sales in 2010 -- $1.15 billion -- was too low; Pfizer put it closer to $2 billion. World-wide sales for all insulin in 2006 were $8.7 billion, according to Credit Suisse. Last year, Exubera finally cleared regulatory review but with a label that cautioned against its use by smokers or asthmatics and recommended regular lung exams. Pfizer bought out Sanofi's share of the product for $1.3 billion. The news that Pfizer was abandoning Exubera came as a surprise to Nektar of San Carlos, Calif., from which Pfizer licensed Exubera. Nektar issued a scathing news release late yesterday accusing its partner of a poor marketing job and of not alerting Nektar it would be terminating their licensing deal. Pfizer says it told Nektar of its plans minutes after releasing the news, because the announcement was material for both companies. MNKD ASH is May 19, 2016, 1.5 months from 4/5/2016 Afrezza independent day. Hopefully, a settlement will be reached before 5/19/2016. m.facebook.com/MannKind-Corporation-237759248628/Pfizer spent more than $2.5B, TV Ads, expansion in Canada, and still paid Nektar $135M settlement. Pfizer makes nice with Nektar It’s not surprising that Pfizer has settled with nice package of $135 million for withdrawing from the Exubera contract. (See details of settlement at www.biospace.com/news_story.aspx?NewsEntityId=77240 ) Pfizer is rightfully concerned about losing its status as a “preferred partner” for potential future lucrative licensing deals with biopharma companies. This status allowed them to gain licenses for blockbusters Lipitor and Celebrex from Parke Davis and Searle, respectively, companies which Pfizer eventually acquired. audreysnetwork.wordpress.com/tag/pfizer-settlement-with-nektar/
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Post by lakers on Apr 8, 2016 16:29:52 GMT -5
Source says Matt is still negotiating a Sanofi settlement as of today and that the next Afrezza partners will be multiple small regional partners in the size of RLS $100M deal each. It won't be a single BP like SNY, in case you wonder where the funding sources come from for many critical hires.
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Post by lakers on Apr 2, 2016 12:13:50 GMT -5
RBC Keeps MannKind (MNKD) at 'Underperform'; Afrezza Plans in Limbo Until CCO Hired RBC Capital reaffirms MannKind (Nasdaq: MNKD) at Underperform with a price target of $0.15 following Q4 results and update issued Monday night. ANalyst Adnan Butt commented, While MNKD has an approved diabetes drug in its hands in Afrezza and technosphere platform could have value in future drug development, we would like to see execution on four fronts before becoming constructive: 1) Afrezza sales ramping up into the tens of millions; 2) technology partnerships or a fast-to-market proprietary drug; 3) path to breakeven; and 4) improved balance sheet. Butt also noted the following from the company's conference call: Plans for Afrezza still undetermined although a CCO is hired. MNKD hired Michael Castagna from Amgen to lead commercialization. However, the company did not shed light on specific strategy for “relaunching” Afrezza and how it plans to address market penetration, doctor and patient education, payor/reimbursement, and other issues related to the brand. Management also did not commit to having plans in place around when Afrezza is reacquired around April 5. Afrezza demand trends show declines in market share as Sanofi disengages. Since Oct 2015, Afrezza’s market share ceiling is 0.25% when compared against other fast-acting insulins and had a market penetration of 0.19% based on IMS Rx data through 10/2/15. More recent data through 3/4/16 shows market penetration at ~0.09%, which may reflect Sanofi backing off sales efforts. MNKD may see a pickup in Rx once they “relaunch” although turnarounds are fairly challenging. www.streetinsider.com/dr/news.php?id=11419475
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Post by lakers on Mar 31, 2016 17:26:06 GMT -5
Might GS be working on an investment banking deal or retained by Mnkd to explore strategic options ? That's why they dropped coverage.
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Post by lakers on Mar 30, 2016 23:44:20 GMT -5
Why Goldman Is Still Selling Mannkind by Manikandan Raman10 hours ago MNKD SNY Goldman Sachs maintained its Sell rating on MannKind Corporation (NASDAQ: MNKD) as it believes the recent rally in shares is not related to fundamentals as news flow is negative since Sanofi SA (ADR) (NYSE: SNY) dropped out of the Afrezza partnership in January. "Specifically, Afrezza is averaging 400 TRx's per week in Feb/Mar down from 500 in 4Q15. At this rate, Afrezza scripts are only ~20% of the level Exubera reached at the same point post launch," analyst Jay Olson wrote in a note. "Recognizing that Sanofi invested in physician and consumer targeted promotional campaigns to educate and create awareness for Afrezza, we are concerned that Afrezza scripts may continue to decline in the absence of Sanofi's marketing muscle and substantial diabetes expertise. It is unclear to us how MNKD intends to finance the promotion of Afrezza which has so far been costly and unprofitable." As of December 31, MannKind had about $60 million in cash and $30 million available to borrow from the Mann Group. Olson said Sanofi reported total Afrezza end market sales of only $8 million in 2015 resulting in about $170 million net loss of which MannKind owes Sanofi about $60 million for their 35 percent share. Shares of MannKind were down 0.29 percent at $1.73, while Olson has a price target of $0.25. m.benzinga.com/article/7777641?utm_referrer=https%3A%2F%2Fwww.google.com%2F
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Post by lakers on Mar 28, 2016 17:05:20 GMT -5
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Post by lakers on Mar 24, 2016 18:32:38 GMT -5
rew12.ultipro.com/MAN1011/JobBoard/JobDetails.aspx?__ID=*B0E22B018AC905B0Requisition Number 16-0008 Post Date 3/24/2016 Title VP, Market Value, Access & Trade City Valencia State CA Description In this position reporting to the Chief Commercial Officer this newly created position of Vice President of Market Value, Access and Trade will be responsible for the development, implementation and management of business strategies to enhance managed care and product access of current and future company products through an analytical market-focused approach; provides a strategic vision and acts as a transformational agent of change within the organization; acts as the senior leader for managed care sales and trade strategies; help ensure proper allocation of resources, ROI measurement for key managed care business initiatives and to improve contracting options/negotiations. Develop, implement and communicate the managed care strategy for the Company; establish short-term and long-term goals and tactics to improve access and utilize resources efficiently. Coordinate and implement formulary and reimbursement strategies. Develop key relationships within the Payer community to increase collaboration, support positive coverage policy, improve contracting processes and enhance reimbursement for supported products.
Present company products to managed care organizations as needed. Evaluate the overall strategies for individual payers and with the goal of accelerating coverage timelines and increase revenue.Design and implement processes to ensure that medical information and messaging about significant product-related events is efficiently and effectively disseminated to key managed care decision makers, limiting negative impacts and leveraging positive product developments. Manage the overall contract negotiation process and pull-through programs with managed care organizations using an analytical approach. Is up to date on all government policies related to reimbursement of our products. Establish a relationship/partnership in the area of government affairs. Attend trade shows, managed care meetings and conventions. Partner with Marketing, Sales, Finance, Legal, Regulatory, Executive Committee and other internal departments to develop business strategies to enhance managed care access for company products and increase profitability. Help develop the overall product value proposition, including positioning and product specifications. Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Requirements BA/BS required. Master’s degree preferred. Payer and PBM account management experience required. Minimum 10 years of related experience within the pharmaceutical industry with a track record of documented success is required. Minimum 5 years of Managed Care specific experience is required. Must have experience working with commercial managed care payers. Proven track record of personal contributions regarding the managed care strategic planning process, successful strategy execution (with coordination of internal and external resources), and results (growth). Proven success in new product and line extension launches with Payers and PBMs. Demonstrate ability to manage internal and external relationships. Contracting experience with Payers and PBMs. Demonstrated commitment to corporate philosophy and values. Interpersonal Skills: Connecting with Others, Teamwork, Concern for Impact, Relationship Building, Integrity. Results Orientation: Focus on Goals, Self Confidence, Growth Mindset, Inner Drive for Success, Learn and Develop. Ability to Influence Others: Focus on Customer Agenda, Win-Win, Communication Skills, Collaboration. Business Acumen: Sound Judgment, Critical Thinking, Problem Solving, Analytical Thinking. Leadership: Motivates Others, Develops Others, Leverages Authority, Leads and Adapts to Change, Models the Vision, Organization Awareness. Willingness to travel as needed (>40%)
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Post by lakers on Mar 24, 2016 18:27:55 GMT -5
healthamerica.coventryhealthcare.com/web/groups/public/@cvty_regional/documents/webcontent/c152093.pdfFrom Kevinmik Coventry has Afrezza listed as Standard Coverage and is dropping prerequisite requiring one or more other drugs be used before coverage is approved. Conventry Health Care July 1, 2016 Formulary Changes (Standard) Abbreviation Key Refer to your plan documents for a complete description of benefits, exclusions and limitations of coverage NPB/G Non-preferred brand-name or nonpreferred generic drug These drugs aren’t preferred. You may pay higher out-of-pocket costs when using a non-preferred brand-name or generic drug ST = Step therapy Step therapy only applies if your plan includes step-therapy. This means that you must try one or more prerequisite drug(s) before we cover a step-therapy drug. Pg 7/26: March 1, 2016 and April 1, 2016 Formulary Changes (Standard) 81.03.411.1 (3/7/16) UPPERCASE = brand-name drug; lower case italics = generic drug Drug Name Current Tier Tier as of 3/1/16 Formulary Alternative(s) Notes AFREZZA NPB/G NPB/G Remove STfinance.yahoo.com/mbview/searchview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&q=coventry&in=b&sm=Several million members: (this press reslease is a few years old) HARTFORD, Conn. & BETHESDA, Md.–(BUSINESS WIRE)–Aetna (NYSE: AET) and Coventry Health Care, Inc. (NYSE: CVH) today announced that they have entered into a definitive agreement pursuant to which Aetna will acquire Coventry in a transaction valued at $7.3 billion, including the assumption of Coventry debt.(1) Coventry is a diversified managed health care company that offers a full portfolio of risk and fee-based products, including Medicare Advantage and Medicare Part D programs, Medicaid managed care plans, group and individual health insurance, coverage for specialty services such as workers’ compensation, and network rental services. The acquisition is projected to add nearly 4 million medical members and 1.5 million Medicare Part D members to Aetna’s membership. On a pro forma basis, the transaction increases Aetna’s share of revenues from Government business to over 30 percent from 23 percent currently.
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