UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2023
(Exact name of registrant as specified in its charter)
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(203 ) 404-0410
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 Regulation FD Disclosure
Analyst and Investor Meetings
On January 10, 2023, Biohaven Ltd. will be making an investor presentation (the “Presentation”). A copy of the Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number* | Exhibit Description | |||||||
| 99.1 | ||||||||
| 104 | The cover page of this Current Report on Form 8-K formatted as Inline XBRL. | |||||||
* The XBRL instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: January 10, 2023
| Biohaven Ltd. | |||||
| By: | /s/ Matthew Buten | ||||
| Matthew Buten | |||||
| Chief Financial Officer | |||||
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41st Annual J.P. Morgan Healthcare Conference Vlad Coric, M.D., Chairman and Chief Executive Officer January 10, 2023
Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Biohaven Ltd. (the “Company”) and our planned and ongoing trials for our BHV-2100, troriluzole, BHV-5500, BHV-1100, BHV-1200, Taldefgrobep Alfa, BHV-7000 and BHV-7010 development programs, the timing of and the availability of data from our clinical trials, the timing and our decisions to proceed with our planned regulatory filings, the timing of and our ability to obtain regulatory approvals for our product candidates, the clinical potential utility of our product candidates, alone and as compared to other existing potential treatment options, and the potential advancement of our early phase programs including ARM™, MATE™, MODE™, TRPM3, TDP-43, UC1MT and Kv7. The use of certain words, including “continue”, “plan”, “will”, “believe”, “may”, “expect”, “anticipate” and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of our development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements. You should, therefore, not rely on these forward- looking statements as representing our views as of any date subsequent to the date of this presentation. Additional important factors to be considered in connection with forward-looking statements are described in the Company’s filings with the Securities and Exchange Commission, including within the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. This presentation also contains market data and other information based on industry publications, reports by market research firms or published independent sources. Some market data and information is also based on the Company’s good faith estimates, which are derived from management’s knowledge of its industry and such independent sources referred to above. January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference2
Pfizer Acquisition of CGRP Platform $13B
Because we are passionate about the work we do everyday — FRANCINE Through state- of-the-art drug discovery and passionate scientists — LARRY With a powerful R&D engine — JAVIER We never forget patients need us. — JEREMY With a commitment to transforming patients’ lives — KATRINA
HIGH VALUE PLATFORMS INNOVATIVE PORTFOLIO PROVEN BUSINESS FORMULA Pursuing novel paths of science to transform the treatment of neurological and neuropsychiatric diseases A broad therapeutic portfolio addressing patient needs with intention. Formula for continued growth built upon past success of experienced team and a resilient focus on creating value for patients and shareholders
January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference6 DRUG OR PLATFORM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET ION CHANNEL Kv7 ACTIVATOR BHV-7000 BHV-7010 ION CHANNEL TRPM3 BHV-2100 GLUTAMATE Troriluzole MYOSTATIN CD38 Bispecific targeted cell therapy DISCOVERY RESEARCH IgG degrader IgA degrader Next-gen ADC platform BHV-4157 | SPINOCEREBELLAR ATAXIA (SCA) BHV-4157 | OBSESSIVE-COMPULSIVE DISORDER (OCD) BHV-2000 | SPINAL MUSCULAR ATROPHY (SMA) BHV-1100 | MULTIPLE MYELOMA BHV-7000 | EPILEPSY, MOOD DISORDERS BHV-7010 | EPILEPSY, MOOD DISORDERS BHV-2100 | CHRONIC PAIN
Key Programs
Kv7 Ion Channels: Key Regulators of Neuronal Function 5 FAMILY SUBTYPES Primary localizations: • Kv7.1: cardiac • Kv7.2: CNS BHV-7000/7010 activator • Kv7.3: CNS BHV-7000/7010 activator • Kv7.4: smooth muscle and inner ear • Kv7.5: vascular tissue, neurons, skeletal muscle Kv7 Stria Vascularis Organ of Corti Vascular tissue Gastrointestinal tract Adventitia Media Intima Inner Ear Cardiac Muscle Skeletal Muscle Neuron Axon initial segment Node of Ranvier Synapse Serosa Muscle layer Mucosa Submucosa January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference8 Source: PHYSIOLOGY 26: 365–376, 2011; doi:10.1152/physiol.00009.2011 (Maria Virginia Soldovieri,1, Francesco Miceli,2,3 and Maurizio Taglialatela1,2)
Kv7 Potassium Channels Regulate Neuronal Excitability and Loss of Function Causes Epilepsy January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference9 Impaired Kv7 Channel Activity Causes Certain Types of Epilepsy Kv7 Activation Normalizes Action Potential Firing Loss-of-function mutations in Kv7.2 channel Abnormal EEG with Epileptic Activity Dalen Meurs-van der Schoor, Front Pediatr (2014). Hyperexcitability — Epilepsy and Mood Disorders Adapted from Wulff, Nat Rev Drug Discov (2009) . Increased frequency of action potential firing Normal frequency of action potential firing Kv7 channel activator Kv7
January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference10 Kv7 PLATFORM Focal Epilepsy Potential Best-in-Class, Fast-Follower Approach Clinically validated mechanism of action Pursuing Differentiation Preclinical data suggests wide therapeutic index in the clinic by dialing out GABA risk (somnolence, sedation, dizziness) Translatability Preclinical data in epilepsy models is predictive of clinical efficacy Broad Potential in Adjacent Indications Warrants further evaluation in BPD, depression, pain, others Patent Protection Both BHV-7000 and BHV-7010 covered until 2039 Status Update BHV-7000 Phase 1 SAD/MAD study completed (Canada) BHV-7010 IND anticipated in 2023
BHV-7000 is chemically stable to photo-oxidation BHV-7000 is selective for Kv7 over GABAA receptors a BHV-7000 has a wide therapeutic index preclinically a 1st and 2nd Gen Kv7 Activators Show Clinical Anti-seizure POC, But Off-target Activities, Opportunity for 3rd Gen Kv7 Differentiation XEN1101 • XEN1101 and ezogabine significantly greater GABAA receptor allosteric activators than BHV-7000 in vitroa • GABAA receptor activation: somnolence, dizziness, fatigue, diplopia Ezogabine XEN1101 BHV-7000 G A B A A A ct iv at io n a (% B as el in e) 0 20 40 60 GABAA Posi ive Allosteric Modulation % In cr ea se fr om b as el in e 10 µM BHV-7000 10 µM EZO 10 µM XEN1101 ✱✱ ✱✱ 0 20 40 60 GABAA Positive Allosteric Modulation % In cr ea se fr om b as el in e 10 µM BHV-7000 10 µM EZO 10 µM XEN1101 ✱✱ ✱✱ ** ** ** significantly different from BHV-7000, all tested at 10 µM EZOGABINE • Unstable when exposed to light • Label warnings for skin discoloration • Black box warning for retinal abnormalities/vision loss FDA Drug Safety Communication: Potiga (ezogabine) [04-26-2013] BHV-7000 • Potent activator of Kv7 channels • Effective and well-tolerated in preclinical seizure assays Th er ap eu tic In de x Ezogabineb XEN1101b BHV-7000a 10 20 30 40 50 Kv7 January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference11 a. Biohaven data on file (2022). b. Calculated as ratio of TD50 (rotarod) to ED50 (MES seizure assay) data presented by Xenon at Epilepsy Foundation Pipeline Conference, San Francisco (Feb 2018). Preclinical results are consolidated from separate reports and graphed together. Data presented is not the result of any head-to-head clinical trials and does not mean or suggest that BHV-7000 is clinically more safe and effective.
BHV-7000 Exhibits Highly Differentiated Preclinical Profile January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference12 Wide Therapeutic Index Kv7.2/7.3 Activator GABAA Activity “dialed-out” Ezogabine XEN1101 BHV-7000 Activator, clinical and preclinical anti-seizure activity Activator, clinical and preclinical anti-seizure activity Activator, clinical and preclinical anti-seizure activity GABAA activity present GABAA activity present Negligible GABAA activity <3x reporteda,b >40xb<5x reporteda Kv7 a. Calculated as ratio of TD50 (rotarod) to ED50 (MES seizure assay) data presented by Xenon at Epilepsy Foundation Pipeline Conference, San Francisco (Feb 2018). b. Biohaven data on file (2022). Preclinical results are consolidated from separate reports and not a result from head-to-head comparisons Data presented is not the result of any head-to-head clinical trials and does not mean or suggest that BHV-7000 is clinically more safe and effective.
BHV-7000 Phase I SAD/MAD Study Update: Dosing Completed Preliminary Safety • Single doses up to 100 mg and multiple doses up to 40 mg daily x15 days generally well-tolerated • Most AEs mild and resolved spontaneously • No serious or severe AEs • No dose limiting toxicities Preliminary Pharmacokinetics • Target concentrations for efficacy exceeded based on preclinical MES model • High fat meal had no effect on exposures Pooled adverse events from SAD and MAD cohorts occurring in more than 1 subject (preliminary blinded data including BHV-7000 and placebo groups) January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference13 Kv7 Pooled Adverse Events* N = 61 Headache 7 (11.5) Back pain 3 (4.9) Constipation 2 (3.3) Abdominal discomfort 2 (3.3) Urinary frequency 2 (3.3) * MedDRA® Preferred Term
Kv7 In mania models, Kv7 activation reduces hypermetabolism and hyperactive behavior1 Robust MDD efficacy likely to translate to bipolar disorder2 fMRI study: ezogabine effects mediated by the limbic system Preclinical and Clinical Data Suggest a Role for Kv7 in Bipolar Disorder and Depression January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference14 1. Kristensen et al. J Neurochem (2012). 2. Costi et al. Am J Psychiatry (2021); 178(5):437-446. 3. Golberg et al. J Clin Psychiatry (2021) 82(1):20ed13649 DECREASING BRAIN HYPERACTIVITY Retigabine normalizes a mania model hypermetabolic signature to a higher degree than lithium Mania 3/3 positive studies of fluoxetine in bipolar depression indicate effects in MDD translate to bipolar disorder3 Depression Vehicle Lithium 120 mg/kg Retigabine 10 mg/kg ~7pt decrease vs placebo with ezogabine in depression symptoms Ch an ge in M AD RS sc or e Weeks 0 -5 -10 -15 -20 0 1 2 3 4 5 Ezo gab ine Plac eb o 0.8 0.6 0.4 0.2 0.0 -0.2 -0.4 Ch an ge in V S ac tiv at io n to re w ar d an tic ip at io n (o ut co m e > ba se lin e)
Epilepsy Blockbuster Peak Sales Potential for Kv7 Platform January 10, 2023 Mood Disorders Biohaven | 41st Annual J.P. Morgan Healthcare Conference15 ✓ Easy to Prescribe Convenient dosing, no titration, no food effect ✓ Safe/Tolerable Side effects negatively impacted other recent epilepsy launches ✓ Biohaven Proven Commercial Expertise in Neuroscience 1. https://www.cdc.gov/epilepsy/data/index.html (1.2% of the population has epilepsy, 60% is focal onset). 2. Kammerman S. West J Med. 2001 Aug;175(2):99-103. 3. Hauser WA. Epilepsia. 1991 Jul-Aug;32(4):429-45. 4. https://www.nimh.nih.gov/health/statistics/bipolar-disorder (2.8% of US adults have had BPD within last year and 4.4% of population over their lifetime). 5. Hasin DS. JAMA Psychiatry. 2018 Apr 1;75(4):336-346. Kv7 34.5M MAJOR DEPRESSIVE DISORDER (US)5 200–300 KCNQ2-DEE incidence in live births 3.5M EPILEPSY PATIENTS adult and pediatric, US1–3 1.1M 2.4M Treatment refractory/ uncontrolled patients Focal epilepsy patients 7–11M BIPOLAR DISORDER (US)4
TRPM3: A Novel Peripheral Target for Neuropathic Pain January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference16 Differentiated from existing programs targeting TRPV1 and TRPA1 • Current SoC comes with liabilities — addiction (opioids), sedation • Pre-clinical data shows reversal of pain in various models, without sedative effects • IND planned for 2H 2023 Appeared effective, but class terminated for hyperthermia despite significant investment X Difficult target to drug with PK/solubility issues; remains in active drug development (Lilly) Conflicting data for pro- and anti-nociceptive role; remains in active drug development Promising as a novel target: expressed at similar levels as TRPV1 and TRPA1 in peripheral neurons but unlikely to have thermal liabilities See Koivisto et al, Nature Reviews Drug Discovery 2022 for background on TRP channel drug development. Peripheral sensory neuron Pain sensation CGRP
BHV-2100 Reduces Pain in Preclinical Models of Chemotherapy and Diabetic Neuropathy Encouraging evidence of pain reduction without the sedation observed with high dose tramadol/gabapentin January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference17 BHV-2100 5 mg/kg BHV-2100 25 mg/kg Tramadol 5 mg/kg BHV-2100 1 mg/kg Vehicle BHV-2100 1 mg/kg BHV-2100 25 mg/kg Pregabalin 30 mg/kg Gabapentin 150 mg/kg BHV-2100 5 mg/kg Vehicle DISCOVERY RESEARCH Drug administered 7 days after diabetic induction with STZ in rats Drug administered 6 days after oxaliplatin in mice
January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference18 TRORILUZOLE SCA and OCD SPINOCEREBELLAR ATAXIA (SCA) • Reduction in fall risk + treatment effect in SCA3 genotype • Safe and well-tolerated profile • Regulatory engagement planned for H1 2023 OBSESSIVE COMPULSIVE DISORDER (OCD) • Compelling mechanistic rationale for cortico-striatal glutamate abnormalities in OCD patients • Strong PoC in Phase 2 • Well-characterized in 1,000+ patients • Two Phase 3 studies ongoing; enrollment completion anticipated YE 2023
January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference19 TALDEFGROBEP ALFA SMA Pivotal Phase 3 Study Initiated July 2022 • Large pre-clinical and clinical safety package licensed from BMS • Limited additional work needed to support BLA submission • 34 sites total, 13 open POC for Mechanism of Action Supported by clinical data and multiple disease models Muscle and Bone Improvements Observed in non-clinical studies Strong Supporting Efficacy Signal Muscle mass growth in healthy subjects Large Safety Database Established in prior pediatric studies
• Harnesses the body’s own machinery for degrading proteins • Extracellular protein targets are eliminated via the asialoglycoprotein receptor (ASGPR) • Protein targets are degraded via endolysosomal proteolysis * formerly BH 2640 Bispecific Platform: IgG Degradation via MoDE™ January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference20 DISCOVERY RESEARCH MoDE small molecules bind extracellular target proteins and cause them to be removed from the body through the liver Binds liver (ASGPR) Binds protein target Pathogenic target protein and MoDEs in circulation
Pan-IgG Degrader (BHV-1300) Shows Superiority Over SoC (Efgartigimod) DISCOVERY RESEARCH Efgartigimod: Cyno PD 0 5 10 15 0 25 50 75 100 125 Days % Ig G , ba se lin e vehicle 10 mg/kg 75 mg/kg 250 mg/kg BHV-1300: Cyno PD 3 days 75% depletion 5–7 days 50% depletion January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference21 IND ready in H2 2023
DISCOVERY RESEARCH Bispecific Platform: IgA Degrader for IgA Nephropathy Therapeutic Hypothesis: Galactosyl deficient-IgA (Gd-IgA) containing-immune complexes drive glomerular injury in IgA nephropathy.1 Specific removal of this pathogenic Gd-IgA with preservation of “normal” IgA (and other Ig’s) permits disease remission without incurring an infection risk. • Highly selective, rat mAb conjugate binds Gd-IgA with high affinity • Antibody humanization ongoing, subsequent conjugation with established degrader technology will allow rapid and efficient hepatic extraction, leaving “normal” IgA January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference22 1. Canetta et al, 2014, others. 2. Untested therapeutic hypothesis. anti-Gd-IgA antibody Liver Antibody-based MoDE removes Gd-IgA Gd-IgA removal drives efficacy without infection risk2 Chimeric antibody-ASGPR ligand conjugate specifically mediates endocytosis of galactose deficient IgA 0.1 1 10 100 1000 10000 0 200000 400000 600000 800000 1000000 nM M FI Chimeric KM55 ASGPR ligand conjugate specifically mediates endocytosis of galactose deficient IgA galactose deficient IgA normal serum IgA M ea n Fl uo re sc en ce In te ns ity
Bispecific Platform: CD38 Targeted Cell Therapy for Multiple Myeloma CD38 Antibody Recruiting Molecule (ARM™) • Modular bispecific molecules with two moieties, each designed for non-covalent binding to a specific target • Redirect endogenous antibodies to target cancerous or virally infected cells for immune destruction January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference23 Key Potential Advantage Over Biologics ü Lower manufacturing cost ü More versatile — smaller and tunable ü Faster and less expensive to develop ü Better safety and efficacy • Non-immunogenic; better dosing • Enhanced PK properties • Reduce NK cell fratricide compared to daratumumab ARM BHV-1100 CD38 Targeting Therapy Mult iple Mye lom a Cell Multipl e Myelo ma Cell Multiple Myeloma CellNK Cell BHV-1100 + CIML NK cell CD38 ARM™ Binds to CD38 receptor on the surface of multiple myeloma cells
Ex Vivo Patient Plasma Study: 4 Out of 5 Patients Showed Reduction in Plasma Cells (Multiple Myeloma) January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference24 ARM Using patient bone marrow and a combination therapy % reduction in plasma cells in patient bone marrow +/- autologous CIML NK cells in presence of BHV-1100 0 20 40 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 % re du ct io n in C D 38 + C D 13 8+ P C * * * * Patient blood samplePatient bone marrow Isolate NK cells 1. Bone marrow 2. BHV-1100 4 hrs 1. Bone marrow 2. BHV-1100 3. CIML NK cells Readout % CD38+ CD138+ plasma cells Generate CIML NK cells overnight ONGOING CLINICAL STUDY MRD + post-transplant multiple myeloma patients ongoing at Dana Farber Institute • First patient survival to one year • Two additional patients randomized Journal of Clinical Oncology 2020 38:15_suppl, 8523-8523. BHV-1100 + no NC cells BHV-1100 + CIML NK cells
Second-generation ADC-linker technologiesBiohaven third-generation technology DISCOVERY RESEARCH Bispecific Platform: Advancing Next-Generation, Site-Specific Antibody Drug Conjugates (ADCs) Potential for best-in-class A single residue per heavy chain is available for conjugation • Controlled DAR* ratio is critical to therapeutic index • MATE tech precisely defines DAR* Improved linker stability should yield wider therapeutic index • Improved safety: less systemic, untargeted payload • Improved efficacy: targeted payload delivered to tumor Uses native antibody: potentially improved CMC vs. current tech N N N N O O O Payloadn n O O O Payload N H Click chemistry to engineered antibody January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference25 *DAR = Drug antibody ratio 0 0.1 0.2 0.3 0.4 0.5 1 2 3 4 5 6 Fr ac tio n La be lle d Residue Peptide Mapping (typical cartoon) 0 0.2 0.4 0.6 0.8 1 1 2 3 4 5 6 Fr ac tio n La be lle d Residue Peptide Mapping (typical cartoon)
Capitalization Considerations CGRP royalties: Pfizer will make royalty payments in low- to mid-teens% in respect of annual U.S. net sales of rimegepant and zavegepant >$5.25B, subject to annual cap ($400M/year)3 ~$540 million2 SHARE O/S CASH POTENTIAL ROYALTIES 1. Excludes 9.1 million options ($7.00 strike price). 2. As of October 2022. 3. Cap reached if aggregate annual U.S. net sales of rimegepant and zavegepant amount to $8.15B. Royalty payments would be in respect of years ended on or before 12/31/40. January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference26 68.2 million1
File IND Near-Term Milestones (Anticipated) January 10, 2023Biohaven | 41st Annual J.P. Morgan Healthcare Conference27 DRUG NAME INDICATIONS 2H 2022 1H 2023 2H 2023 BHV-7000 Kv7 channel activator Focal epilepsy Bipolar disorder BHV-7010 Kv7 channel activator Epilepsy and mood disorder BHV-2100 TRPM3 Chronic pain disorders Troriluzole NCE prodrug of riluzole Spinocerebellar ataxia Obsessive-compulsive disorder Taldefgrobep alfa Anti-myostatin adnectin Spinal muscular atrophy BHV-1300 IgG degrader Undisclosed Milestone achieved Regulatory Interaction Complete Enrollment Initiated Phase 3 Initiate Phase 2/3Initiate EEG StudyPhase 1 Topline Initiate Phase 2/3 File IND File IND
Pursuing novel paths of science A broad therapeutic portfolio Formula for continued growth HIGH VALUE PLATFORMS INNOVATIVE PORTFOLIO PROVEN BUSINESS FORMULA