Horizon Pharma disclosed that it received a civil investigative demand today from the United States Department of Justice pursuant to the Federal False Claims Act regarding assertions that certain of its payments to pharmacy benefit managers were potentially in violation of the Anti-Kickback Statute. The CID requests certain documents and information related to payments to pharmacy benefit managers, pricing and patient assistance program regarding Deuxis, Vimovo and Pennsaid 2%, Horizon disclosed in a regulatory filing. It added, “We intend to cooperate with the investigation. While we believe that our payments and programs are compliant with the Anti-Kickback Statute, no assurance can be given as to the timing or outcome of the DOJ’s investigation, or that it will not result in a material adverse effect on our business.”
Tuesday, March 5, 2019
Cooper Companies raises FY19 EPS view to $11.85-$12.15 from $11.30-$11.70
Consensus $11.57. Raises FY19 revenue view to $2.63B-$2.68B from $2.6B-$2.66B, consensus $2.64B.
https://thefly.com/landingPageNews.php?id=2874757
https://thefly.com/landingPageNews.php?id=2874757
Ligand Sells Promacta Assets and Royalty for $827M; Updates Guidance
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and Royalty Pharma announce the sale of Ligand’s Promacta®-related intellectual property rights licensed to Novartis, including the royalty stream on worldwide net sales of Promacta to Royalty Pharma for $827 million in cash. Promacta (eltrombopag) is known as Revolade®outside the U.S. and is marketed worldwide by Novartis. This transaction is expected to close on Wednesday, March 6, 2019.
“After extensive consideration, we determined it is in the best interest of Ligand stockholders to monetize our Promacta assets. We are very proud of our discovery contribution to this billion-dollar molecule and best-in-class medicine for a vital medical market. The product has been a big part of our success, driving the company to profitability and generating significant cash flows through the years,” said John Higgins, Chief Executive Officer of Ligand. “We are pleased to work with Royalty Pharma on this deal. They are the world’s largest royalty investor and have extensive experience investing in royalty-bearing assets. We share a common view with Royalty Pharma that owning royalties is a highly efficient and effective way to participate in the potential of the pharmaceutical industry.”
“In addition to receiving an attractive and substantial valuation for the future royalties, this transaction allows Ligand to focus investment of the cash proceeds into assets and companies that will drive financial growth five, 10 years and beyond. This transaction doubles our investable cash to over $1.4 billion while preserving what we view as our most valuable assets: our portfolio of partnered programs and our OmniAb technology platform. We have a promising horizon of business-development opportunities, and remain committed to obtaining potential royalties through internal development, acquisition and technology out-license to drive revenue growth. We also remain committed to implementing our investment strategy with relatively low and tightly managed operating expenses in order to maximize cash-flow and profits per share for all stockholders,” Higgins added.
“We are pleased to partner with Ligand in this important transaction, in which Ligand has transformed an intangible asset into capital it can use to drive future growth in its core business” said Pablo Legorreta, Founder & CEO of Royalty Pharma. “Ligand’s contribution to the discovery of Promacta is a testament to the ability of Ligand’s technology platforms to produce innovative therapies with blockbuster potential. At the same time, Royalty Pharma is pleased to expand its portfolio of royalties on innovative blockbuster drugs by acquiring certain rights, title and interest in the leading therapy for immune thrombocytopenia and other serious bleeding disorders. This is truly a win-win transaction for both Ligand and Royalty Pharma.”
Highlights of the transaction to monetize the Promacta royalty include:
- Provides substantial cash payment for Ligand’s leading royalty asset.
- Ligand’s 2019 revenues are now expected to be approximately $118 million and 2019 adjusted diluted EPS to be approximately $32.25, compared to the previous guidance of $6.05.
- Proceeds to be reinvested by Ligand primarily to 1) acquire assets that can generate long-term revenue streams, fully-funded Shots on Goal and technology platforms to drive future deal making and 2) share repurchases to increase the per share profits and cash-flow for the existing business.
- Ligand will enter the second quarter of 2019 with highly-diversified and high-growth revenue streams, more than 200 Shots on Goal fully funded by partners, three major technology platforms to drive new licensing and over $3.5 billion of potential contract payments with existing partners.
- At the close of the transaction, Ligand estimates it will have over $1.4 billion of cash.
In addition, the long-term growth potential for the OmniAb platform is accelerating, given R&D progress by partners and new licensing transactions. As discussed during Ligand’s fourth quarter 2018 earnings call, OmniAb holds potential to generate $500 million to $1 billion in future annual royalty revenue.
Ligand has a substantial upcoming calendar of clinical, regulatory and commercial events for leading partnered assets including VK-2809, Sparsentan, ZULRESSO™, RVT-1502 and expanded clinical data for Kyprolis, as well as Ligand’s internal pipeline including Captisol-enabled iohexol and internal antibody-based programs.
Promacta Highlights
- Launched in 2008, generated $291 million of royalties for Ligand over the past 11 years.
- Annual sales have increased at a 32% compound annual growth rate over the past five years.
- Worldwide patents expected to expire between 2021 and 2028.
- Achieved and maintained a leadership position in a category that has had multiple new products enter the market over past 12 months.
The sale of Ligand’s Promacta assets will be made pursuant to an asset purchase agreement between the parties in which Royalty Pharma will acquire the research, development and license agreement between Novartis Pharma AG (as successor in interest to SmithKline Beecham Corporation) and related assets from Ligand, and assume certain related liabilities.
2019 Financial Guidance
Ligand is providing updated guidance for 2019 with total revenues now expected to be approximately $118 million, which includes royalties of approximately $48 million, material sales of approximately $27 million and license fees and milestones of approximately $43 million.
Ligand notes that with total revenues of $118 million, adjusted diluted EPS would be approximately $32.25. This EPS estimate assumes a diluted share count for the year of approximately 21.5 million.
This compares with previous guidance for 2019 total revenues to be approximately $224 million, including royalties of approximately $154 million, material sales of approximately $27 million and license fees and milestones of approximately $43 million. Previous guidance for adjusted diluted EPS was approximately $6.05.
Ligand is also providing guidance for the first quarter of 2019 for total revenues of at least $38 million, and adjusted diluted EPS of approximately $30.00. First quarter revenue breakdown is projected to be approximately $19 million in royalties, including $15 million of Promacta royalties estimated for the first two months of 2019, $12 million in license fees and milestones and $7 million of material sales. There is potential for approximately $5 million in additional royalties and contract payments during the first quarter based on the timing of milestones and sales levels for royalty-bearing assets.
Conference Call
A conference call and webcast with slides will be held today at 5:00 p.m. Eastern time (2:00 p.m. Pacific time), which will be hosted by Ligand’s CEO John Higgins, President and COO Matt Foehr and CFO Matt Korenberg. To participate please dial (833) 591-4752 from within the U.S., or (720) 405-1612 from outside the U.S., using Conference ID 9786043. The slides as well as the webcast and an archive of the webcast will be accessible through www.ligand.com.
Study at HCA Hospitals Shows Significant Reduction in Bloodstream Infections
HCA Healthcare (NYSE: HCA), a leading healthcare provider with 185 hospitals and more than 1,800 sites of care in 20 states and the United Kingdom, today announced a study published in the current issue of The Lancet and conducted exclusively at HCA Healthcare hospitals has shown an infection control technique achieved a 31 percent reduction in bloodstream infections and nearly a 40 percent reduction in antibiotic-resistant bacteria among non-ICU patients with central line catheters and lumbar drains.
As a result of the study, HCA Healthcare has begun implementing the infection prevention protocol in its hospitals.
“This reflects HCA Healthcare’s commitment to be a true learning healthcare system,” said Jonathan B. Perlin, MD, HCA Healthcare’s president, clinical services, and chief medical officer and one of the study’s authors. “We use the knowledge we capture from delivering care to millions of patients a year for continuous improvement and innovation, not only to fuel our own quality improvement efforts but also to solve vexing societal challenges such as infection prevention.”
Healthcare-associated infections (HAIs) such as methicillin-resistant Staphylococcus aureus (MRSA) are a serious patient safety issue and their elimination is a top priority for the U.S. Department of Health and Human Services (HHS). On any given day, about one in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.
The study, known as the ABATE Infection (active bathing to eliminate infection) Trial, is part of a national strategy to reduce HAIs. The study was conducted through a longstanding collaboration among HCA Healthcare, Harvard Pilgrim Health Care Institute, the University of California Irvine, and Rush University. The ABATE Trial was funded by the National Institutes of Health with contributed effort from HCA Healthcare. ABATE was conducted at 53 HCA Healthcare hospitals during a 21-month period involving 330,000 patients. Because it was a large-scale, pragmatic trial—a study conducted under “real world” conditions at community hospitals—the results of ABATE are believed to be generally applicable to hospitals across the country.
A learning health system, which uses data from approximately 31 million annual patient encounters to help continuously improve care, HCA Healthcare maintains the healthcare field’s largest system for analyzing clinical data. This makes HCA Healthcare desirable for conducting “pragmatic trials” such as ABATE because the patients are cared for in a single system whose diversity reflects community hospitals across the country and whose data management system facilitates large scale analysis.
“The ABATE Infection Trial was made possible by the remarkable infrastructure of HCA Healthcare to conduct pragmatic clinical trials to impact patient care,” said Susan Huang, MD MPH, professor in the division of infectious diseases at the University of California, Irvine School of Medicine. “Here, we found that by implementing specific antiseptic protocols, we could prevent serious infections in patients with medical devices.”
The ABATE Infection Trial builds on the REDUCE MRSA Trial research conducted at HCA Healthcare hospitals and published by the New England Journal of Medicine in 2013 that documented how intensive care units in HCA Healthcare hospitals dramatically reduced infections and antibiotic resistant bacteria. Conducted among non-ICU patients, the ABATE Trial evaluated whether daily bathing with the antiseptic soap chlorhexidine (CHG)—and in those patients with MRSA, adding the nasal antibiotic mupirocin—more effectively reduced hospital-acquired bacterial infections than bathing with ordinary soap and water. While no significant difference between the two intervention groups was seen within the population overall, the researchers did find that patients with medical devices experienced a substantial benefit if they received the CHG/mupirocin intervention. Compared to patients outside the intervention, they experienced a 31 percent decrease in bloodstream infections and a nearly 40 percent decrease in antibiotic resistant organisms, specifically MRSA and vancomycin-resistant enterococcus (VRE).
Although only 12 percent of patients in the study had central lines and lumbar drains, because these devices can be an entry point for infections, patients with them accounted for 37 percent of MRSA and VRE clinical cultures and more than half of all bloodstream infections.
The antiseptic product was contributed by Sage Products and MoInlycke. The companies providing product to the trial had no role in the design, conduct, analysis or publication of the ABATE Infection Trial.
Chimerix price target lowered to $7 from $10 at H.C. Wainwright
H.C. Wainwright analyst Edward White lowered his price target for Chimerix to $7 from $10 following the company’s Q4 results and platform updates. The company reported that due to regulatory and site initiation delays, Phase 2 AdAPT study enrollment is expected to be substantially delayed beyond the projected 2019 timeframe, which will push back top-line data from the 16-week primary endpoint that was expected in 2020, White tells investors in a research note. The analyst now project an oral brincidofovir launch in 2022 in adenovirus patients, with sales of $61M that year. He keeps a Buy rating on Chimerix.
T2 Biosystems weakness attributed to White Diamond short report
Weakness in shares of T2 Biosystems is being attributed to a short report published earlier on Seeking Alpha by White Diamond Research. In the report, White Diamond claims that T2’s system “is becoming a commercial flop like other bacteremia (bacteria in the blood) testing diagnostic systems before it.” The research firm, which set a $1.50 price target on T2 Biosystems shares, added that “in every 2018 quarter, TTOO’s unsustainable research revenue was higher than its much more important product revenue.” In afternoon trading, T2 shares are down 59c, or 14%, to $3.70
ObsEva setting up steady clinical catalysts lineup, says Credit Suisse
ObsEva setting up steady clinical catalysts lineup, says Credit Suisse Credit Suisse analyst Martin notes that ObsEva used its earnings call to highlight that it may have six Phase 3 trials active in 2019 across linzagolix and nolasiban, setting up a steady clinical catalysts lineup, with nolasiban IMPLANT 4 results coming in Q4 of 2019. If results are positive, the company plans to file an MAA submission by the end of Q4 2019, with a potential 2020 EU approval, he contends, adding that ObsEva sees nolasiban as having blockbuster potential, with an attractive value proposition to patients, clinics, and the overall health system. Meanwhile, the analyst highlighted that the company plans to meet with FDA Q2 2019 to reach agreement on the U.S. approval strategy for nolasiban. Auster reiterates an Outperform rating and $24 price target on the shares.
Subscribe to:
Posts (Atom)