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Tuesday, March 12, 2019

Convene Partners With Healthcare Startup For Clinics In Coworking Spaces

As part of its effort to be all things to all office users, Convene is bringing a new kind of amenity to flexible offices. A new partnership with healthcare startup Eden will place clinics within Convene’s flexible office footprint.
The clinics can serve as primary care contacts for Convene members and other office tenants in the building, and can use virtual healthcare technology to consult with specialists and save square footage. Convene has been testing its model with Eden for a year, and plans to open at least 25 locations across its existing footprint across the next 18 months, according to the announcement.
Its roll-out will begin in New York, Chicago, Philadelphia, Washington, D.C., Boston and Los Angeles later this year.
Convene started out as a provider of on-demand event spaces, then transformed itself into a flexible office space operator in February 2018 by partnering with landlords rather than renting from them. Like coworking name brand WeWork, it has added elements and offerings at a rapid pace, driven by investment capital from real estate sources such as Brookfield and RXR Realty.
In September, Convene began offering its design and flex office management services as a service to landlords, rather than a branded entity within their buildings. Similar in concept to WeWork’s Powered by We service, it reflects the office industry’s growing acceptance of flexible office providers as not just a subletter, but an amenity. Convene’s partnership with Eden adds to the modern concept of an office that draws employees in by filling more of their needs beyond desk space.

Guardant Health sees FY19 revenue $130M-$135M, consensus $116.88M

https://thefly.com/landingPageNews.php?id=2878124

Baxter tells Bloomberg not in talks with Akorn, has no plans to submit offer

https://thefly.com/landingPageNews.php?id=2878078

Eli Lilly Could Sustain Industry-Leading Growth: JPMorgan

Eli Lilly And Co LLY 0.28% is the best-positioned among large caps, given healthy core product growth, a growing portfolio of new launches and next-gen pipeline assets, potential for significant margin expansion and several sources of near- and long-term upside, according to JPMorgan.

The Analyst

JPMorgan’s Chris Schott moved to an Overweight rating on Eli Lilly with a year-end price target of $140 while adding the stock to the Analyst Focus List.

The Thesis

Eli Lilly could deliver 6-8-percent topline growth and mid-teens annual EPS growth through the next 10 years, Schott said in a Tuesday note.
The company’s growth prospects are supported by a diversified portfolio of new launches, the analyst said. The global pharmaceutical firm is better positioned than its peers, since none of its products constitute more than 20 percent of sales, he said. Lilly’s diabetes, immunology and pain franchises seem poised for healthy growth through 2024, Schott said.
Diabetes remains a key driver for the company, with Trulicity continuing to beat expectations, the analyst said. A marked increase in Jardiance uptake has taken place in recent months, he said,
JPMorgan expects Trulicity sales to growth from an estimated $4.2 billion in 2019 to $6 billion by 2023, while Jardiance sales are expected to grow from around $1 billion in 2019 to $2 billion by 2023.

Biopharma stocks should be up sharply on Sharpless selection, says Piper Jaffray

Piper Jaffray analyst Christopher Raymond said he expects biopharma stocks to be up sharply on news that former National Cancer Institute director Ned Sharpless will be named acting FDA commissioner. The biotech sector “experienced a swoon of sorts” since Scott Gottlieb announced his departure, but with the announcement of Gottlieb’s favored choice as successor Raymond believes the FDA will remain “on its current industry-friendly and efficiency driven trajectory,” the analyst tells investors.
https://thefly.com/landingPageNews.php?id=2878041

Ligand: Highlights from Today’s Analyst Day

Webcast available at www.ligand.com
At an Analyst Day event held today in New York City, Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reviewed the recent progress of its business and financial growth outlook. Management provided additional details on its 2019 financial guidance and a preliminary financial outlook for 2020, discussed its technology platforms, including the opportunity and importance of its OmniAb technology platform.
Highlights of the event’s presentations include the following:
Business model and growth drivers:
  • Management provided an overview of Ligand’s business model and diversification of its portfolio. Ligand leverages its diversification with Shots on Goal, which are programs fully-funded by partners and backed by Ligand’s patents, know-how and/or data. These Shots on Goal provide economics to Ligand on program success without the associated spend.
  • Ligand has increased its Shots-on-Goal portfolio to more than 200 programs, with four technology platforms and more than $3.5 billion in potential contract payments from partners. Ligand has more than 1,200 patents issued worldwide and more than $1.4 billion in cash currently on its balance sheet.
    • Today’s presentation included slides that breakout the $3.5 billion in potential contract payments by technology, by product stage of development and by partner. The presentation also included an analysis of the over 200 Shots on Goal by technology, by stage of development and by type of partner.
  • Ligand expects its revenue and diluted EPS to grow at a compound annual growth rate (CAGR) in the mid-teens percentages for the next five to 10 years.
  • Ligand has 112 employees, including 45 with a Ph.D. degree and 88 in R&D, with an average tenure at the company of 10 years. These employees work from facilities in San Diego and Emeryville, California, Lawrence, Kansas and Cambridge, England.
  • Major assets reviewed at the Analyst Day event include VK-2809 (Viking Therapeutics), ZULRESSO (Sage Therapeutics), Sparsentan (Retrophin), Captisol-enabled-Iohexol (internal), RVT-1502 (Metavant) and expanded use for the marketed drug Kyprolis® (Amgen and Ono Pharmaceuticals), which uses Ligand’s Captisol technology in its formulation.
  • Management outlined Ligand’s “RPT” (Revenue, Pipeline, Technology) foundation of value, and highlighted 2016 to 2020 projected CAGRs of 30% for royalties (excluding royalties from Promacta), 7% for material sales and 17% for contract payments.
OmniAb technology:
  • OmniAb is a best-in-class technology and is Ligand’s most valuable business unit, with a current estimated standalone valuation estimated as $2 billion to $2.5 billion based on various internal analyses.
    • OmniAb currently includes four animal platforms and three species, with an expected launch in 2019 of OmniClic, a common light chain OmniChicken for the discovery of bispecific antibodies.
  • Ligand estimates that more than 400 antibody campaigns have been initiated by OmniAb partners, and that its partners will spend approximately $500 million over the next 12 months advancing OmniAb-based programs.
  • Today there are 12 OmniAb programs in the clinic, and Ligand projects there will be more than 30 programs using OmniAb-discovered antibodies in the clinic by 2021.
    • By 2030, Ligand projects that more than 1,000 OmniAb campaigns will have been initiated and 25 to 35 OmniAb products on the market.
    • Based on current market sizes and royalty rates, Ligand projects potential for between $500 million and $1 billion in annual OmniAb royalties in 2030.
  • The likelihood of approval at Phase 1 for antibody drugs is approximately 11.5%, compared with approximately 6.2% for small-molecule drugs based on historical data, and that the selling antibodies currently on the market have more than $4 billion in annual sales.
    • By 2024, antibody drugs are expected to represent 12 of the Top 20 best-selling drugs (up from seven of the Top 20 in 2017), with antibody drug sales exceeding $94 billion (up from $57.4 billion in 2017).
  • Ligand disclosed at the Analyst Day event an internal OmniChicken antibody program that was initiated in mid-2018, and currently includes five immuno-oncology targets. Ligand intends to initiate partnering discussions for these targets in the second half of 2019.
Captisol-enabled Iohexol:
  • Ligand has a history of creating value by investing in internal R&D to drive partnering events with upsized licensing terms. Investments in R&D have created some of the company’s most valuable licenses.
  • In addition to the OmniChicken program discussed above, at today’s event Ligand reviewed its CE-Iohexol program, which follows past success with Captisol-enabled melphalan (now EVOMELA®). Ligand spent approximately $2 million on EVOMELA R&D and to date has received 10 times the cash return on that investment having received over $21 million in cash payments. Ligand holds an ongoing 20% royalty on net sales of EVOMELA, and worldwide sales are projected to grow.
  • CE-Iohexol is designed to reduce acute kidney injury (AKI) during medical interventions, including imaging procedures using iodinated contrast agent administration. This program was established in 2018 and a Phase 1 clinical trial is currenting launching, with data expected in the second half of 2019.
    • More than 30 million imaging procedures are performed each year in the U.S. AKI is a continuing issue with broad medical visibility. Currently no products are approved to prevent or treat AKI in this setting.
Financial overview and outlook, and investment philosophy:
  • Management highlighted Ligand’s history of strong revenue growth and its expectations for continued growth in the near- and long-term. Revenue growth has contributed to significant cash flow and per-share earnings.
  • Ligand affirmed 2019 guidance for total revenue of approximately $118 million ($48 million from royalties, $27 million from materials sales and $43 million from contract payments), gross margin of more than 92%, total cash expenses of $48 million to $52 million, EBITDA margin of approximately 50%, a tax rate of 21% to 23%, and adjusted diluted EPS of more than $32.25, including a one-time gain on the sale of the Promacta® royalty of $29.05 per share and $3.20 per share from operations.
  • The company provided a preliminary outlook for 2020 financials, noting that formal 2020 guidance will be given after trends from 2019 are confirmed. To assist analysts and investors understand how the company is analyzing the range of potential 2020 guidance, management made the following commentary:
    • Royalties follow sales trends of underlying products, and consensus estimates for sales trends will guide management in firming expectations for 2020. Currently Ligand believes potential royalty revenue growth for 2020 could be in the range of 35% to 50% over 2019.
    • Material sales are driven by partner orders of Captisol for use in commercial activities and clinical trials. Once 2019 orders are known, the company will be able to estimate 2020 material sales. Currently the company expects 2020 material sales to grow 5% to 10% over 2019.
    • Milestone and license revenues are driven by partner annual fees, preclinical and clinical trial progress, NDA-related filings, collaboration revenue and other partner events, and the timing of such events fluctuates based on the progress of Ligand’s partners in developing their programs. The company will be able to more accurately estimate 2020 milestones closer to 2020; however, currently the company expects 2020 milestone and license revenues to exceed those of 2019, with the potential for at least $50 million of contract payments in 2020.
  • Management noted that 2020 corporate gross margin is expected to be in the range of 92% to 94%, that the company’s cash operating expense structure is expected to be approximately $50 million, in line with expectations for 2019, and that EBITDA margin is expected to be approximately 57.5%. These items combined with a share count of 21.5 million equates to adjusted diluted EPS of at least $4.00.
  • Management provided an overview of some of the key financial metrics for Ligand over a five-year outlook. Specifically, management expects a revenue CAGR exceeding 15%, cash operating expenses to remain at approximately $50 million with increases to account for inflation, and EBITDA margin to expand from 50% in 2019 to over 75%, with 5% to 10% annual increases.
  • Management discussed Ligand’s investment philosophy. Ligand has focused its external investments on corporate M&A, royalty investments and purchases, and company formation and seed investments. Ligand has focused its internal investments on its R&D programs and returning cash to shareholders through share repurchases.
  • Ligand provided a summary of its merger and acquisition history. Ligand has made 16 acquisitions and investments over the past 11 years. Having spent $445 million on these transactions, Ligand has already received more than $500 million as a return on these investments. After receiving more than its cash back, Ligand is now positioned to realize significant gains from its 200+ Shots on Goal, its portfolio of $3.5 billion of potential contract payments and its three major technology platforms for new licensing transactions.
Partner presentations:
  • Edward van den Brink, Ph.D., Associate Director, Global Antibody Discovery of GenMab B.V. (GEN.CO), gave an overview of GenMab’s experience and success in using the OmniAb platform’s OmniRat technology. GenMab reports high success rates in using OmniRat for 38 proprietary antibody targets, with 98% sequence homology with rat orthologue and more than 80% of animals develop an antigen-specific titer. He also highlighted Ligand’s continuous innovation of the OmniAb platform as a value-driver for the platform. The anti-PD-L1 arm of GenMab’s Duobody program is OmniRat-derived.
  • Brian Lian, Ph.D., CEO of Viking Therapeutics (NASDAQ: VKTX), gave an overview of VK5211 and VK2809, two Ligand-partnered Phase 2 programs supported by encouraging clinical data. The VK2809 program for NASH is a novel, selective thyroid receptor-b agonist with Phase 2 results that demonstrate significant reduction in liver fat content and lipids. Viking plans to initiate a Phase 2b clinical trial in biopsy-confirmed NASH in 2019.
  • Wes Kaupinen, CEO of Palvella Therapeutics, gave an overview of PTX-022 (QTORINTM rapamycin formulation), which is positioned to be the first and only therapy to address the root cause of pachyonchia congenita (PC), a serious, chronically debilitating, lifelong monogenic disease. He also commented on the near-term potential to expand PTX-022 beyond PC into other areas of unmet medical need. Mr. Kaupinen described an attractive market opportunity in PC, a rare disease state with an estimated annual U.S. revenue opportunity exceeding $300 million. PTX-022 has garnered FDA support including Fast Track and orphan drug designations. Palvella has initiated a Pivotal Phase 2/3 study with data readout targeted for the second quarter of 2020.
  • Jan-Anders Karlsson, Ph.D., CEO of Verona Pharma plc (NASDAQ:VRNA), gave an overview of Verona’s novel first-in-class product candidate ensifentrine (RPL554) for the treatment of respiratory diseases. Ensifentrine’s has a legacy linked to the Vernalis Design Platform. Verona sees an opportunity for ensifentrine in 40% of U.S. COPD patients who are symptomatic despite current treatment. Verona has announced positive interim Phase 2 data with ensifentrine dry powder inhaler formulation in COPD with dose-dependent, significant and clinically meaningful bronchodilator response. Verona sees potential for multiple value-creating inflection points with Phase 2 readouts in 2019 as they prepare for Phase 3 trials.

Humana Starts Bundled Pay for Spinal Fusion, Expands Total Joint Replacement

Humana Inc. (NYSE: HUM) is announcing two key milestones as it expands value-based orthopedic specialty care for Humana Medicare Advantage members, launching a bundled payment model for spinal fusion surgeries, and broadening the reach of its Total Joint Replacement Episode-Based Model for total hip or knee joint replacement procedures.
Humana Launches Spinal Fusion Episode-Based Model, Announces First Program Participants
Humana is teaming up with orthopedic and neurosurgery practices to launch a value-based care bundled payment initiative designed specifically to provide coordinated care for Humana Medicare Advantage members undergoing spinal fusion surgery.
The Spinal Fusion Episode-Based Model (EBM) offers the opportunity for additional payment to physicians and clinicians for improved health outcomes and cost across a member’s entire spinal surgery episode-of-care. Improvement is measured based on three clinical indication rates – readmissions, cervical complications, and lumbar complications – as well as by average risk-adjusted episodic cost-of-care.
The program’s inaugural participants are Fort Wayne Orthopedics and Ortho NorthEast(Indiana), Mayfield Brain & Spine (Ohio), and OrthoVirginia (Virginia).
“We’re excited to focus on spinal fusion surgery with our newest orthopedic episode-of-care model,” said Oraida Roman, Vice President of Humana’s Value-Based Strategies Organization. “This program is a logical ‘next step’ for us in value-based care, considering the prevalence of spine surgeries and, therefore, the need for a coordinated, quality patient experience. We’re deeply committed to sharing our knowledge and experience with participating providers, as we have a mutual dedication to improving clinical outcomes and lowering the cost of spinal care.”
Humana Expands Availability of Total Joint Replacement Episode-Based Model
Humana also is announcing the expansion of its first orthopedic bundled payment program, the Total Joint Replacement Episode-Based Model for Humana Medicare Advantage members undergoing total hip or knee joint replacement procedures.
Through eight additional agreements with orthopedic specialty groups across the nation, the program now is offered at more than 60 medical practices in 19 states, including, for the first time, in Michigan. Humana’s newest agreements are with Southern Bone and Joint Specialists (Alabama); Florida Orthopaedic Institute and Watson Clinic LLP(Florida); Louisiana Orthopaedic Specialists (Louisiana); Michigan Orthopaedic Surgeons (Michigan); Signature Medical Group’s Kansas City-area practices (Missouri); MSK Group, P.C. and Tennessee Orthopaedic Alliance (TOA) (Tennessee); Orthopedic Associates of Central Texas, Rio Grande Orthopedic Center, and The Orthopaedic Center of Corpus Christi (Texas).
Initially launched in 2016, the Total Joint Replacement Episode-Based Model has expanded each year since then. The program is designed to improve quality, outcomes, and cost across a member’s entire joint replacement episode of care, and it offers the opportunity for additional payment for better outcomes.