CANF = Can-Fite BioPharma announced it has concluded an End-of-Phase 2 meeting with the FDA regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer, or HCC, the most common form of liver cancer. The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to the regulatory agency. The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a new drug application, or NDA, submission and approval. The Phase III study will enroll patients with advanced HCC, with underlying Child Pugh B7, or CPB7, cirrhosis, whose cancer has progressed on first line therapy. This design leverages the previously announced Phase II trial data, which showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.
DRNA = Dicerna (DRNA) announced a research collaboration and licensing agreement with Roche (RHHBY) to develop novel therapies for the treatment of chronic hepatitis B virus infection using Dicerna’s proprietary GalXC RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development. The collaboration also includes the discovery and development of therapies targeting multiple additional human and viral genes associated with HBV infection using the technology platforms of both companies. Under the terms of the agreement, Dicerna will receive $200M in an initial upfront payment and may be eligible to receive up to an additional $1.47B over time for the achievement of specified development, regulatory and commercial milestones. In addition, Dicerna may be eligible to receive royalties based on potential product sales of DCR-HBVS. Dicerna retains an option to co-fund pivotal development of DCR-HBVS worldwide, which if exercised, entitles Dicerna to receive enhanced royalties and co-promote products including DCR-HBVS in the U.S. Dicerna and Roche also agreed to collaborate on the research and development of additional therapies targeting multiple human and viral genes implicated in chronic HBV infection, using technology from both companies, for which Dicerna is eligible to receive additional milestones and royalties on any potential products. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.
KHC = Reports Q3 revenue $6.08B, consensus $6.12B. “While our third-quarter results remain below our potential, we showed sequential improvement versus the first half, and I believe we are beginning to operate the business better,” said Kraft Heinz CEO Miguel Patricio. “We are making good progress in identifying and addressing the root causes of past performance, as well as setting our strategic direction. Although there is still much work ahead, we’re encouraged by our improving performance, and are even more confident in our ability to turn around the company and set a path of long term growth and profitability.”
FB = JPMorgan analyst Doug Anmuth says Facebook executed well in Q3 and that its initial 2020 outlook affirmed his view the company can deliver 20’s% revenue growth in 2020 with moderating expense growth, driving re-acceleration in earnings growth next year. Facebook remains his top pick with an Overweight rating and $255 price target.
AAPL = Reports Q4 Mac revenue $6.99B vs. $7.34B last year. Reports Q4 iPad revenue $4.66B vs. $3.98B last year. Reports Wearables, Home and Accessories revenue $6.52B vs. $4.22B last year. . Half of iPad purchasers were new to iPad… Saw five times iPhone trade in volume vs. last year… Giving TV+ to iPhone users is a “gift”… About 75% of Apple Watch buyers are new to Apple Watch… Trade tensions are less, looking more positive… Wearables are doing “so great” in China… Saw key gaming approvals in China in Q4… Expects better China reception as trade tensions wane… Paying some tariffs currently… Tone has changed significantly on tariffs… FX “clearly a headwind for us right now”… Committed to making monthly hardware payments easier… Too early to tell Apple Arcade conversion rate… Apple Arcade off to good start. . Loop Capital analyst Ananda Baruah raised his price target on Apple to $250, saying its Q4 results and guidance were “solid”. The analyst says the company delivered on its iPhone shipment units while its Services and Wearables businesses also performed “well ahead” of expectations. Baruah still keeps his Hold rating on Apple, noting that its current forward earnings multiple of 18.7-times is toward the high end of its 13- to 19-times multiple range over the past 2 years. Needham analyst Laura Martin raised her price target on Apple to $280 and kept her Strong Buy rating after its better than expected Q4 results. The analyst is positive on the company’s competitive position, its “marketing multiplier”, and its “growing utility” with the focus on pay, card, and health businesses along with its new arcade, news, and TV services. Martin adds that bundling its offerings with combinations of family plans, along with free TV+ with new devices, will allow Apple to reduce its churn and boost the average revenue per user. Morgan Stanley analyst Katy Huberty raised her price target on Apple shares to $296 from $289 to reflect slightly higher revenue and stronger cash generation in FY20 following the company’s Q4 results, which she called “clean across the board.” The company’s guidance reflects a positive start to the iPhone 11 cycle and she thinks strength across iPhone, Wearables, and Services are sustainable, Huberty added. She keeps an Overweight rating on Apple shares. Cowen analyst Krish Sankar raised his price target on Apple to $290 from $250 following strong Q4 results. The analyst said optimism around a low-cost 5E2 in the first half of 2020 and a 5G model by late 2020 combined with robust Service trends, could drive further earnings and multiple expansion. Sankar reiterated his Outperform rating on Apple shares. Canaccord analyst T. Michael Walkley raised his price target on Apple to $275 from $260 following its strong Q4 results. The analyst said he was encouraged by the initial strong iPhone 11 demand and estimates its installed base is leading to record Services revenue. The price target increase reflects healthy ongoing iPhone sales with 5G leading to stronger iPhone sales in 2021. Walkley reiterated his Buy rating on Apple shares. Wedbush analyst Daniel Ives raised his price target for Apple to $300 from $265 and maintained an Outperform rating following the company’s quarterly results, which he says will be viewed “positively” by the Street, as many were looking for weakness on the iPhone front given “noise” coming out of China and the smartphone industry. Ives tells investors in a research note that on the iPhone front, China was “well above” expectations and is on the path to showing growth in the region which remains the focus of investors with this key region representing roughly 20% of all iPhone upgrades over the next 12 to 18 months. He also notes that iPhone 11 demand is “tracking comfortably” above original Street expectations.