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Hanmi Pharmaceutical Progress on R&D, B2B Operations, and Exports

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2017. 6. 15 Sector Pharmaceuticals (OVERWEIGHT) Update Earnings growth, R&D results in the spotlight in 2H Team Analysts ● Global, Korean pharma markets to grow 6.3% and 4.4% pa , respectively. Multiple Brian Lee blockbusters to come off patent over 2016-2020, benefiting Korean biosimilar firms. Team Head (Pharm/Biotech) [email protected] ● Sea change from 2012 as Korean healthcare integrates with global ecosystem. 822 2020 7177 Next five years, virtuous circle: stronger brands/track records →→→ financial gains. SunYoung Yoon ● Eye government policy, regulatory direction; visibility to improve in 2H. Be (Pharm/Biotech) [email protected] selective: buy firms with R&D successes, B2B track record, or improving earnings. 822 2020 7840 ● Covered stocks: combined sales, operating profit to grow 14.1%, 47.9% y-y in 2017. Kevin Kim Medical aesthetics to stand out in 2Q; large pharmaceutical, biotech stocks in 2H. (Medical Devices/Medical Aesthetics) [email protected] ● Top picks: Hanmi Pharm, Samsung Biologics, Hugel, Dentium, ST Pharm, Huons. 822 2020 7178 Research Associate WHAT’S THE STORY? Wonyong Park Solid growth ahead for global, Korean pharmaceutical markets: The global [email protected] pharmaceutical market is projected to grow at a 2016-2022 CAGR of 6.3% to reach USD1.12t, while 822 2020 7847 its Korean counterpart should expand at 2017-2021 CAGR of 4.4% to KRW18.6t. Meanwhile, a second patent cliff is ahead: blockbuster drugs (including several biologics) worth USD249b will lose patent protection over 2016-2020. In short, things are looking good for the Korean companies AT A GLANCE that lead the global biosimilar market. Sea change for Korean healthcare: Over 2012-2017, Korean healthcare firms made massive Hanmi Pharmaceutical progress on R&D, B2B operations, and exports. Some signed large out-licensing deals with global (128940 KS, KRW364,000) pharmaceutical firms. Korea-made biosimilars dominate the global market, while Korea-made botulinum toxins and fillers are gaining global market share. We expect Korea to produce the Target price: KRW450,000 (23.6%) world’s top biologics contract manufacturing organization and one of the world’s top-ten chemical- drug contract manufacturing services. Successes over the past five years owe much to the Samsung Biologics (207940 KS, KRW213,500) accumulation of technology, effective business strategies, investments by chaebol , and supportive government policies. Over the next five years, Korean healthcare firms should enter a virtuous cycle wherein stronger brand equities and track records lead to greater financial gains. Target price: KRW260,000 (21.8%) Monitor policy, regulatory direction: Korea’s healthcare industry should benefit if the Hugel (145020 KS, KRW451,900) government keeps election pledges to nurture the pharmaceutical, biotechnology, and medical device industries; halts the introduction of for-profit medical corporations; and raises subsidies for implants, hearing aids, and Alzheimer’s treatments. But prescription-drug makers will suffer if a Target price: KRW570,000 (26.1%) total drug cost limit is enforced. Focus on firms specialized in OTC drugs, supplements, biotech, diagnostics, medical aesthetics, and medical devices. Dentium (145720 KS, KRW37,450) To make visible progress on R&D, B2B fronts: In 2H, Hanmi Pharmaceutical should begin global Phase III clinical trials for Efpeglenatide and resume global Phase I trials for Target price: KRW50,000 (33.5%) HM12525A/JNJ-64565111; Green Cross should win US approval for IVIG; Samsung Biologics should win US and European approval for three biosimilars; Medytox-Allegan should begin global ST Pharm (237690 KS, KRW48,400) Phase III trials for Innotox; Kolon Life Science should win domestic approval for Invossa; Genexine and Qurient should make progress on their B2B operations; and Seegene should begin supplying ODM products to Beckman Coulter. Target price: KRW56,000 (15.7%) Operating profit growth: We have operating profits at our covered large pharmaceutical firms, Huons (243070 KS, KRW58,800) medium-sized pharmaceutical firms, biotech, medical-diagnostics, medical-aesthetics, and medical- device firms growing 32.9%, 12.6%, 123.2%, 26.5%, 51.6%, and 15.6% y-y, respectively, in 2017. Medical aesthetics profits should stand out in 2Q on rising demand. In 2H, large pharmaceutical Target price: n/a firms should shine on base effect and SG&A cost-cutting; biotech firms should shine on export * Share price and financials based on growth. We foresee outstanding earnings growth over 2Q-4Q for Hanmi Pharm, Donga ST, May 26 Celltrion, Seegene, and Hugel. Healthcare 2017. 6. 15 Contents 1H review: Poverty in the p2 midst of plenty Pharmaceutical market p7 outlook Visible progress to be made p32 on R&D and B2B fronts Government policy p52 warrants attention 1H review: Poverty in the midst of plenty Key issues in 2H p68 Healthcare indices largely in line with market in 1H; stock performances diverge Solid earnings momentum p87 in 2H Kospi Medical Supplies Index performing in line in 1H: The Kospi Medical Supplies Index Company p105 peaked at 11,297 on Jun 10, 2016, bottomed at 6,988 on Dec 2, 2016, and bounced back to stand at 8,888 on May 26, 2017. The index is up 17.1% ytd, in line with the Kospi’s ytd gains of 16.2%. The index excluding Samsung Biologics was valued as high as 40.1x P/E (Jul 22, 2016) and as low as 18.5x (Nov 18, 2016). It was valued at 26.2x on May 26, 2017. Kosdaq Pharmaceutical Index underperforming in 1H: The Kosdaq Pharmaceutical Index peaked at 7,552 on Feb 5, 2016, bottomed at 5,662 on Mar 24, 2017, and crept back up to stand at 6,209 on May 26, 2017. The index is down 1.3% ytd, underperforming the Kosdaq, which has gained 2.3%. The index’s P/E valuation peaked at 39.4x (Jan 29, 2015) and hit bottom at 24.6x (Mar 24, 2017). It was valued at 26.3x on May 26, 2017. Sector sentiment weakening: Investors have been in thrall to the IT sector in 1H on prospects of record earnings amid a semiconductor supply shortage and smartphone launches. Cyclical sectors have also appealed to those who anticipate US infrastructure investments and inflation under President Trump. In contrast, the belief that the US has begun a period of rate hikes has reduced the investment appeal of high-multiple sectors. Sentiment towards the healthcare sector weakened after Hanmi Pharmaceutical in 2016 announced that some out-licensing contracts it signed in 2015 have been revised or canceled. The sector has remained lackluster in 1H due to a lack of standout R&D successes and earnings momentum. Still, steep share-price corrections in late 2016 made valuations less demanding, leading shares to bottom out in 1Q. Oversold stocks and those with earnings momentum bounce back in 1H: The Kospi Medical Supplies Index performed in line with the Kospi, but stocks with earnings momentum posted the steepest share-price gains. Among our covered healthcare stocks, Samsung Biologics is up 41.4% ytd, Medytox 42.1%, Hugel 40.7%, Hanmi Pharmaceutical 27.4%, and Yuhan 24.6%. Also, stocks that had plunged more than 50% from their previous peaks have rebounded almost 20% from their lows as bargain hunters snapped them up. Healthcare stocks that have rebounded strongly include Huons Global (45.4%), Hanmi Pharmaceutical (36.8%), Hanmi Science (32.3%), and Jeil Pharmaceutical (30.3%). 2 Healthcare 2017. 6. 15 Korean healthcare indices: Relative performances (Indexed: Jan 1, 2017 = 100) 120 115 110 105 100 95 90 85 80 Jan Feb Mar Apr May Kospi Kospi Medical Supplies Kosdaq Kosdaq Pharmaceutical Kosdaq Medical and Precision Machines Source: QuantiWise, Samsung Securities Kospi sector indices: Year-to-date performances (%) 40 30 20 10 0 (10) Gas Banking Telecom Financing Securities Insurance Machinery Chemicals Electronics Distribution Non-metallic Construction Iron and Metal Iron Paper and Wood and Paper Medical Precision Medical Drug and Medicine Drug and Trans. and Storage and Trans. Food and Beverage and Food Textile and Wearing Textile Transport Equipment Transport Note: As of May 26 Source: QuantiWise, Samsung Securities Kospi vs Kospi Medical Supplies Index vs Kosdaq Pharmaceutical Index (Pts) Sep 30, 2016 (Pts) Mar 19, 2015 Nov 5, 2015 Boehringer Ingelheim Out-licensed 12,000 Out-licensed Quantum terminated HM61713 contract 2,400 HM71224 project to Sanofi 2,300 10,000 to Eli Lilly 2,200 8,000 2,100 6,000 2,000 1,900 4,000 Nov 9, 2016 1,800 2,000 Donald Trump wins 1,700 US election 0 1,600 2015 2016 2017 Kospi Medical Supplies (LHS) Kosdaq Pharmaceutical (LHS) Kospi (RHS) Source: QuantiWise, Samsung Securities 3 Healthcare 2017. 6. 15 Korean healthcare indices and sub-sectors: Relative performances (Indexed: Jan 1, 2015 = 100) 300 250 200 150 100 50 0 2015 2016 2017 Kospi Medical Supplies Kosdaq Pharmaceuticals Kosdaq Medical and Precision Machines Medical aesthetics Diagnostics Note: Medical aesthetics (Medytox, Hugel, Humedix, Pharma Research Products, Caregen) Diagnostics (Seegene, i-Sense, Boditech Med, AccessBio) Source: QuantiWise, Samsung Secutieis Korean healthcare indices and sub-sectors: Performances relative to parent index (%pts) 200 150 100 50 0 (50) 2015 2016 2017 Kospi Medical Supplies Kosdaq Pharmaceuticals Kosdaq Medical and Precision Machines Medical aesthetics Diagnostics Note: Kospi Medical Supplies index is compared to Kospi, the rests are to Kosdaq Source: QuantiWise, Samsung Securities Korean healthcare indices: Forward P/E (x) 80 60 40 20 0 2015 2016 2017 Kospi Medical Supplies Kospi Medical Supplies (excl. Samsung
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    OHCA Webinar Wednesday, March 10, 2021 Review Board 4:00pm Please register for the webinar at: https://zoom.us/s/97305655255 After registering, you will receive a confirmation email containing information about joining the webinar. Drug Utilization The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – March 10, 2021 DATE: February 22, 2021 NOTE: In response to COVID-19, the March 2021 DUR Board meeting will be held via OHCA webinar at 4:00pm. Please register for the meeting using the following website address: https://zoom.us/s/97305655255 After registering, you will receive a confirmation email containing information about joining the webinar. Enclosed are the following items related to the March meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Quarterly Review of the Medication Therapy Management (MTM) Program – Appendix B Update on Medication Coverage Authorization Unit/Spring 2021 Pipeline Update – Appendix C Action Item – Vote to Prior Authorize Anjeso® (Meloxicam Injection) and Licart™ (Diclofenac Epolamine Topical System) – Appendix D Action Item – Vote to Prior Authorize Oxlumo™ (Lumasiran) – Appendix E Action Item – Vote to Prior Authorize Fintepla® (Fenfluramine) – Appendix F Action Item – Vote to Prior Authorize Teriparatide – Appendix G