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Thursday, June 27, 2019

ImmunoGen: Announces Completion of Operational Review

Company Will Prioritize Continued Development of Mirvetuximab Soravtansine and a Select Portfolio of Earlier-Stage Candidates
Cash Runway Extended Through Readout of Mirvetuximab Soravtansine Pivotal Trial in Ovarian Cancer
Conference Call to be Held at 8 a.m. ET Today
ImmunoGen, Inc., (Nasdaq:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the completion of an in-depth operational review designed to extend the Company’s cash runway and deliver on its commitment to develop next-generation ADCs to bring more good days to patients and generate increased value for shareholders. Based on the outcomes of this review, the Company will prioritize continued development of mirvetuximab and a select portfolio of three earlier-stage product candidates targeting solid tumors and hematological malignancies. The Company will end the current quarter with approximately $240 million on its balance sheet and expects this cash, together with expense reductions resulting from the operational changes announced today and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.
The operational review commenced following the announcement that FORWARD I, ImmunoGen’s Phase 3 clinical trial evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, did not meet the primary endpoint. Data from FORWARD I did, however, demonstrate a consistent efficacy signal across a range of parameters in the pre-specified subset of patients with high FRα expression. Following consultation with the U.S. Food and Drug Administration (FDA), the Company will pursue a new Phase 3 study in this patient population.
In light of these developments and with the goal of extending the Company’s existing cash runway, ImmunoGen has established three strategic priorities for the business: execute a registration study for mirvetuximab in platinum-resistant ovarian cancer; advance a select portfolio of earlier-stage product candidates; and further strengthen its balance sheet through partnering. Consistent with these priorities, ImmunoGen will focus on the following core activities:
  • Initiate the registration study for mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year;
  • Complete enrollment and continue follow up in the ongoing FORWARD II mirvetuximab combination cohorts;
  • Continue IMGN632 development in patients with relapsed acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and other CD123-positive hematologic malignancies in collaboration with Jazz Pharmaceuticals;
  • Advance two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, which is in co-development with MacroGenics with an IND expected by the end of 2019; and the Company’s next generation anti-FRα ADC, which is expected to enter development in mid-2020; and
  • Monetize its remaining portfolio and platform technologies through out-licensing transactions or asset sales.
Correspondingly, the Company will reduce ongoing expenses through the following portfolio prioritization and restructuring initiatives:
  • Discontinue the development of IMGN779 in adults with relapsed/refractory CD33-positive AML;
  • Suspend all other research activities;
  • Reduce its workforce by approximately 220 employees, with a majority of these employees separating from the business by mid-July 2019; and
  • Seek to sub-lease excess office and lab space.
Following a transition period, the savings generated by the restructuring are expected to reduce ImmunoGen’s quarterly expenses by more than 50%. As a result of the workforce reduction, the Company expects to record a one-time charge totaling approximately $16.4 million related to termination benefits and other related expenses. This charge is expected to be recorded in the quarter ending June 30, 2019, and the related cash payments will be substantially paid out by June 30, 2020. In addition, an anticipated charge of $3.7 million is expected to be incurred for retention benefits in the same time period. Updated 2019 financial guidance will be provided when ImmunoGen announces it second quarter operating results on August 2,2019.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8 a.m. ET to discuss these results. To access the live call by phone, dial 1-786-789-4797; the conference ID is 6921368. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through July 9, 2019.
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Sanofi: FDA to review MenQuadfi, a meningococcal vaccine candidate

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi’s MenQuadfiTMMeningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis. The target action date for the FDA decision is April 25, 2020.
The recently submitted BLA includes positive data from Phase II and Phase III clinical trials held in the U.S. to seek an indication for use of the vaccine in persons 2 years of age and older. If approved, MenQuadfi will be available in a fully liquid presentation.
Phase II and Phase III trials have been performed in the U.S., the European Union (EU), Asia and Latin America. Sanofi is conducting additional Phase III trials in these same regions and Africa. The ongoing clinical development program includes different ages ranging from infants 6 weeks of age through older adults. Given the different vaccines schedules in the U.S. and worldwide, the program’s objective is to assess the vaccine’s ability to help protect individuals from meningococcal meningitis, and address the worldwide needs for meningococcal disease prevention across a broad age range. MenQuadfi’s safety and efficacy data have not yet been evaluated by any regulatory authority.
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Bayer board welcomes appointment of Ken Feinberg as mediator

The Supervisory Board of Bayer AG met for a full day session on Wednesday to discuss the company’s current situation and took a number of decisions to address the current challenges facing Bayer, including those articulated by stockholders at the recent Annual Stockholders’ Meeting and in the ongoing dialogue with investors. The Supervisory Board elaborated on the further action related to the litigation strategy for upcoming cases and resolved on specific measures designed to address the course of the company’s ongoing glyphosate litigation and mediation activities. The Supervisory Board recognizes the negative effect the litigation uncertainty has had on the stock price and stakeholder perception, and is determined to help the company decisively but prudently advance the matter. To this end, a newly established Supervisory Board committee will intensively monitor these topics, consult with the Board of Management and make recommendations on the litigation strategy. It will be equally composed of shareholder and employee representatives and made up of eight Supervisory Board members, several of whom have gathered extensive experience with complex litigations.
In addition, U.S. lawyer John H. Beisner has been retained to advise the Supervisory Board on matters related to the glyphosate litigations, including trial tactics and mediation, on an ongoing basis. His appointment is intended to add fresh and independent perspec¬tives to the advice given to the Board of Management. Beisner will attend the meetings of the new committee. He will also regularly report to the Supervisory Board in his advisory capacity. A recognized expert in product liability litigation, Beisner heads up the Mass Tort, Insurance and Consumer Litigation department of the prominent law firm Skadden in Washington, D.C. Beisner has served in key leadership roles in several high-profile product liability cases, including successful defenses and settlements on behalf of large multinational companies. “We are convinced that with his expertise, John H. Beisner will provide very valuable and concrete advice on the ongoing litigation as well as the mediation,” said Werner Wenning, Chairman of the Supervisory Board.
The Supervisory Board also dealt with the court-ordered mediation process in connection with the glyphosate litigation. In parallel to the continued litigation of further cases, Bayer looks forward to constructively engaging in the mediation process. Both the Board of Management and Supervisory Board welcome the appointment of Ken Feinberg as mediator. “Ken Feinberg has an excellent reputation and an outstanding track record as mediator in some of the most complex settlements in recent years. Working with him will ensure a professional and thoughtful approach in the upcoming discussions,” Wenning said.
The company is also making good progress with its plan to further strengthen Supervisory Board expertise in particular with regards to food and agriculture. “We are in discussions with excellent and high-profile candidates,” Wenning said, while also stressing that the Supervisory Board is currently well positioned to address the challenges facing Bayer thanks to the comprehensive expertise of its members.
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J&J trial: AG Hunter says opioid makers tried to ‘brainwash’ prescribers

Oklahoma Attorney General Mike Hunter said Wednesday he believes evidence has shown that Johnson and Johnson was a “kingpin” in an opioid crisis that has killed about 7,000 Oklahomans as the midpoint was reached in a Cleveland County District Court trial.
“We’ve demonstrated that the defendant engaged in shadowy collaborations and conspiracies with other opioid manufacturers to … brainwash prescribers with pseudoscience and false studies and to suborn policy makers from addressing the epidemic in a decisive way,” Hunter said during a brief hallway news conference. “They’ve marketed … highly addictive opioids as safe, with a low rate of addiction, whenever their internal medical advisory board advised them not to do so.”
John Sparks, Oklahoma counsel for Johnson & Johnson and Janssen Pharmaceuticals Inc., issued a news release Wednesday that presented a far different opinion of the evidence presented in the case to date than the one offered by the attorney general.
“For four weeks, we have heard the State make vague, one-size-fits-all claims without any evidence that the company caused opioid abuse or misuse in Oklahoma,” Sparks said. “Facts matter, and as we have said from the beginning and look forward to showing again in our case, the company’s marketing was squarely within the regulations, and it did everything a responsible manufacturer and seller of opioid pain medications should do. The facts will also show the company’s medicines have helped patients with pain.”
After 22 days of testimony, the state essentially completed presenting its case Wednesday in a trial where Johnson & Johnson and its subsidiaries have been accused of creating a public nuisance through false and deceptive marketing efforts that understated the addictive properties of opioid painkillers while overstating their therapeutic benefits.
Johnson & Johnson attorneys are scheduled to begin calling their witnesses 8:30 a.m. Thursday, although attorneys for the state have been granted permission to present one additional witness later in the trial because that witness is on vacation.
The state is asking Judge Thad Balkman to approve a 30-year abatement plan that would require Johnson & Johnson to pay more than $17.5 billion.
Wednesday’s testimony contained plenty of fireworks as Johnson & Johnson attorney Stephen Brody questioned Oklahoma Mental Health Commissioner Terri White about several situations over the past 20 years where Oklahoma boards and agencies passed up opportunities to place limits on opioid prescribing.
Brody asked White if she thought state officials shared some responsibility for the opioid crisis.
“Absolutely not,” White said.
She then launched a tearful defense of efforts by state employees to combat the growing opioid epidemic while they were in the dark about a multi-million dollar marketing campaign by Johnson & Johnson and other opioid manufacturers aimed at increasing opioid sales in the state.
During other testimony Wednesday, it was revealed that Johnson & Johnson sales representatives were urging Oklahoma doctors who were high prescribers of opioids to prescribe even more at the same time those doctors were under investigation for over prescribing.
Johnson & Johnson’s attorney showed Commissioner White a series of reports regarding Oklahoma health professionals who were disciplined for over prescribing or mishandling opioid prescriptions and asked if any state agency had ever notified his company about suspicions they had about the doctors’ activities.
White said she didn’t know, but noted some of the documents she was shown were the results of undercover investigations. She also noted that Johnson & Johnson obtains its own prescribing data on physicians and said Johnson & Johnson never informed the state that it had targeted those doctors for sales calls.
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Grifols upgraded to Overweight from Neutral by JPMorgan

Target $22.50, from $21
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Danaher Announces New Dental Company To Be Named Envista

Danaher Corporation (NYSE: DHR) (“Danaher”) today announced that Envista Holdings Corporation (“Envista” or the “Company”) will be the name of the separate company Danaher intends to create and take public via an initial public offering in the second half of 2019. Envista will be comprised of three operating companies within Danaher’s Dental segment: Nobel Biocare Systems, KaVo Kerr, and Ormco. These businesses have significant positions in dental implants, orthodontics, dental equipment and consumables, and include brands such as Nobel Biocare, KaVo, Kerr, i-CAT, Dexis, Metrex, Pelton & Crane, Ormco, Implant Direct, and Orascoptic. Envista will be led by Amir Aghdaei, who will become President and Chief Executive Officer. Mr. Aghdaei currently serves as Danaher Group Executive with responsibility for the Dental segment.
Mr. Aghdaei stated, “Envista’s name is a combination of two Latin root words: ‘en’, a prefix meaning to be within, and ‘vista’, meaning a view. Our logo of concentric circles represents our ability to collaboratively achieve endless possibilities ahead. The Envista brand reflects the forward-looking energy that embodies our company culture.”
Aghdaei continued, “Envista’s culture will be built on four core values: ‘Better Choices, Better Outcomes,’ ‘Relationships Built on Trust,’ ‘Innovation in Action,’ and ‘Continuous Improvement as a Competitive Advantage.’ Our Danaher heritage helped us shape these values and serves as a strong foundation for our business. The Envista Business System, which will be based on the Danaher Business System, will be our common operating model.”
Envista intends to apply to list its common stock on the New York Stock Exchange. The stock symbol will be NVST.
Envista will employ 12,000 people worldwide. The company’s website is www.envistaco.com.
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Bayer soars as Elliott discloses $1.1B stake

Bayer (OTCPK:BAYRY) shares surged 7.7% overnight in Frankfurt after activist investor Elliot Advisors revealed a $1.1B stake in the embattled company, which faces more than 13,000 separate lawsuits and billions in potential fines and settlements.
It follows Bayer’s hiring of an outside counsel to advise its supervisory board amid a myriad of suits linked to its glyphosate-based weedkiller, known as Roundup, which it assumed following its $63B takeover of Monsanto last year.
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