rdus-8k_20190107.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 7, 2019

 

RADIUS HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-35726

 

80-0145732

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

 

 

950 Winter Street,

Waltham, MA

 

02451

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (617) 551-4000

Not Applicable

(Former name or former address, if changed since last report)

 

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 (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 7.01Regulation FD Disclosure.

 

Attached hereto as Exhibit 99.1 and incorporated herein by reference is a corporate update presentation to be utilized by Radius Health, Inc. at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

The information contained in Item 7.01 of this Form 8-K (including 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”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly provided by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

 

 

99.1

 

Corporate update presentation of Radius Health, Inc.

 

 

 

 

 

2


 

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.

 

 

 

 

 

RADIUS HEALTH, INC.

 

 

 

 

 

 

 

Date: January 7, 2019

 

 

 

By:

 

/s/ Brent Hatzis-Schoch

 

 

 

 

Name:

 

Brent Hatzis-Schoch

 

 

 

 

Title:

 

General Counsel

 

3

rdus-ex991_233.pptx.htm

Slide 1

Radius Health (RDUS) JP Morgan Healthcare Conference JANUARY 7, 2019 Jesper hoeiland Chief Executive Officer Exhibit 99.1

Slide 2

Safe Harbor Any statements made in this presentation relating to future financial or business performance, guidance, conditions, plans, prospects, trends or strategies and other financial or business matters, including regarding the commercialization of TYMLOS® (abaloparatide) injection in the U.S., the development and potential commercialization of our product candidates, clinical trial results, regulatory actions and communications, potential collaborations, future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predicts”, “targets” and similar expressions and their variants, as they relate to Radius Health, Inc. (“Radius”) or its management, may identify forward-looking statements. Radius cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Radius to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization of TYMLOS in the U.S., or potential commercialization of any of Radius’ proposed product candidates if approved (such as marketing, regulatory, patent, product liability, supply, competition and other risks); dependence on the efforts of third parties; dependence on and challenges to our intellectual property rights; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Radius’ business, financial conditions and results of operations and could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation are contained under the caption “risk factors” in Radius’ Annual Report on Form 10-K for the period ended December 31, 2017, along with Radius’ other reports filed with the Securities and Exchange Commission. The forward-looking statements in this presentation represent Radius’ estimate as of the date of this presentation only, and Radius specifically disclaims any duty or obligation to update forward-looking statements.

Slide 3

An Innovation Leader in Osteoporosis and Breast Cancer to support Women’s Health VISION

Slide 4

3 2 2019 and Beyond Lead and Transform Osteoporosis Treatment with Anabolics Establish Standard of Care in Hormonal Treatment of Breast Cancer Leverage Operational and Financial Structure 1 Driving Value from Growing Revenues and Developing Blockbuster-Potential Pipeline

Slide 5

Proven Track Record from Development to Commercialization Osteoporosis Breast Cancer Abalo Early Clinical Abalo-SC Ph 3 and Approval TYMLOS1 Abalo-patch co-development with 3M P3 Preparation Elacestrant Clinical Development P3 Preparation2 Breast Cancer and Other Oncology Investigational Pipeline 1Approval in April 2017; 2 Ph 3 initiated in December 2018 Science-Driven, Investigational Clinical and Regulatory Commercial Corporate 2003 2019 Year

Slide 6

2018 Achievements Strengthened Oncology Organization, Led by Dr. Charles Morris, Chief Medical Officer ✓ Exceeded Guidance with Net Sales Above Upper Range of $95-98M and Y.E. Cash at $235M ✓ Commercial Partnership with 3M and Regulatory Alignment with FDA for Abalo-patch ✓ Expanded TYMLOS Label with ACTIVExtend Phase 3 data ✓ Initiated Phase 3 Abaloparatide Male Osteoporosis Study ✓ Designed Elacestrant Clinical Regulatory Pathway as a Global Registrational Study ✓ Initiated Elacestrant Ph 3 Study in Advanced Breast Cancer ✓

Slide 7

PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET NEXT STEPS* Abaloparatide-SC Osteoporosis Anabolic Subcutaneous Injection US Market Leadership Ex-US Partnerships Abaloparatide-SC Osteoporosis Anabolic Subcutaneous Injection Results in 2020 Abaloparatide-Patch Osteoporosis Anabolic Transdermal Patch Phase 3 Start Mid-2019 Elacestrant ER+ Breast Cancer Oral SERD Global Partnership 2019 Combination Study 2019 RAD140 HR+ Breast Cancer Oral SARM Ph 1a Results Next Generation Hormonal Therapies ER+ Breast Cancer and Other Oncology Indications Pre-Clinical Validation Post-menopausal Women Metastatic HR+ Metastatic ER+/HER2- Men Post-menopausal Women Metastatic HR+ In 2019: Two Innovative Phase 3 Assets with Blockbuster Potential *Expected dates

Slide 8

1 3 2 2019 and Beyond: Osteoporosis Lead and Transform Osteoporosis Treatment with Anabolics Establish Standard of Care in Hormonal Treatment of Breast Cancer Leverage Operational and Financial Structure

Slide 9

Osteoporosis is a Large and Underserved Market * National US prevalence of women 50 yrs+ diagnosed with osteoporosis; Wright et al, JBMR 2014: 29(11): 2520-2526; Truven Health Analytics (IBM Watson Health); ~85% of OP cases postmenopausal; ** Truven Health Analytics (IBM Watson Health) and IQVIA 5.2M Patients 2.7M Patients 40-50k Patients US Prevalence of Women 50 yrs+ Diagnosed with Osteoporosis* Treated with Osteoporosis drugs** Treated with Anabolic Drugs** 0.9M with Fractures < 5% Penetration ~50% Diagnosis Rate Under Treatment of High Risk Osteoporosis Patients with Bone Building (Anabolic) Therapies

Slide 10

Transforming Treatment & Driving Innovation in Osteoporosis Early Treatment with Anabolics to Maximize Patient Outcomes and Drive Market Growth Increase TYMLOS Market Share Transform Use of Anabolics for Treatment of Osteoporosis Abalo-patch Tymlos SC Commercial ✓ ACTIVE ✓ ACTIVExtend ✓

Slide 11

Proven to Reduce the Risk of Fracture Parathyroid Hormone-related Protein Analog which Builds Bone (anabolic) Approved in 2017 for Treatment of Postmenopausal Women with OP with High Risk for Fractures Reduction in Fractures Efficacy from ACTIVE Phase 3 Select Osteoporosis (OP) Therapies Time to Event for Nonvertebral Fractures *USPI and ACTIVE Study; **USPI and FREEDOM Study; ***USPI and FIT1 Study Note: Because clinical studies are conducted under varying conditions and with different patient populations, information observed across studies may not be directly comparable Not for Promotional Use

Slide 12

TYMLOS Consistently Gaining Market Share towards Leadership TYMLOS continues growing, now at 40% new patient share (NBRx**). Accelerating growth as the only promoted anabolic drug and leveraging innovative pricing strategy Source: IQVIA NPA Monthly and New to Brand Monthly, through December 2018. NBRX: New Patients To Brand Drug; *Q4 2018 to date estimated with IQVIA NPA and New to Brand Weekly, data through week ending 11.30.2018 *Measured in Patients Month on Therapy (PMOT). Tymlos PMOT (also number of pens) = (IMS Extended Units TRx / 1.56ml)* (30 daily doses / 30 days) Forteo PMOT = (IMS Extended Units TRx / 2.4ml)* (28 daily doses / 30 days) ** Exit Market Share measured in December 2018 TYMLOS Price Increase: +5.9% (effective as of January 1, 2019)

Slide 13

Proven to Build Bone with TYMLOS, Maintain with Antiresorptive ACTIVExtend clinical trial with first line TYMLOS, followed by alendronate Primary Endpoint: 18 Months 84% (95% CI: 58, 94) Relative Risk Reduction With TYMLOSàALN vs PlaceboàALN 4.7% (95% CI: 2.7, 7.0) Absolute Risk Reduction TYMLOSàALN (n=544) Placeboà ALN (n=568) 5.6% (n=32) 0.9%‡ (n=5) Exploratory Endpoint: 43 Months Percentage of Patients With New Vertebral fractures* TYMLOS (n=690) Placebo (n=711) 86% (95% CI: 61, 95) Relative Risk Reduction With TYMLOS vs Placebo 3.6% (95% CI: 2.1, 5.4) Absolute Risk Reduction 4.2% (n=30) 0.6%† (n=4) TYMLOS [package insert]. Waltham, MA: Radius Health, Inc; 2017; *Bone HG, et al. J Clin Endocrinol Metab. 2018;103(8):2949–2957 Not for Promotional Use

Slide 14

TYMLOS is Growing the Anabolic Market Source: IQVIA NPA. Measured in Patients Months on Therapy (PMOT). TYMLOS PMOT (also number of pens) = (IMS Extended Units TRx / 1.56ml)* (30 daily doses / 30 days) Forteo PMOT = (IMS Extended Units TRx / 2.4ml)* (28 daily doses / 30 days) Anabolic Volume % Growth versus Prior Year by Quarter* Q2 2017 CAGR 2011-15 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 TYMLOS Approval Q4 2018 8% avg volume growth in 2018

Slide 15

Out of pocket, coverage Abalo-Patch: Innovative and Transformative Anabolic Market Research Top Reasons to Not Prescribe Abalo-Patch Needle Averse Patients Needle Phobic Patients Expected Compliance Convenient Route of Administration Expected to Increase Anabolic Usage as a result of Higher Patient Acceptance, Improved Compliance and Less Training Required by Physicians Source: Market Research data on file (Q4 2018, n=200 physicians)

Slide 16

Abalo-Patch: Persistence and Success in Development Pathway Co-developed with 3M since 2009; IP up to 2037 Pathway for ≥ 75% Non-inferiority against SC* Radius and 3M Progressing CMC and Clinical Supplies Scaling up Manufacturing; Major Equipment in Construction Abaloparatide Tmax (hour) T1/2 (hour) Cmax (pg/ml) AUC (pg*h /ml) Subcutaneous Injection (n=77) 0.47 1.7 598 936 Optimized Patch (n=20) 0.50 1.6 447 915 *: Aligned with FDA on clinical trial design. Randomize ~500 patient Ph 3 study with post-menopausal OP at high risk of fracture. Primary endpoint: Change in lumbar spine BMD at 12-months On Track to Start Phase 3 in Mid-2019 Optimized to Achieve PK Target Profile

Slide 17

Projected peak market and share Abalo-Patch Blockbuster Potential in a Tripled Anabolic Market Today Tymlos SC Forteo Abaloparatide TD Tymlos SC Teriparatide (branded and unbranded ) Anabolic prescribers* Anabolic low-to-non-prescribers* 2018E 20% 80% 47% 13% 40% 21% 26% Quantitative Survey Results: Anabolic therapy market evolution to peak potential (U.S.) Source: Market Research data on file (Q4 2018, n=200 physicians) 338 1,028 Thousands of PMOTs (Pens)

Slide 18

1 3 2019 and Beyond: Breast Cancer Lead and Transform Osteoporosis Treatment with Anabolics Establish Standard of Care in Hormonal Treatment of Breast Cancer Leverage Operational and Financial Structure 2

Slide 19

Driving Results in Breast Cancer Develop Elacestrant* in Combination Partnership Develop Elacestrant* as Monotherapy Become the Leader in Hormone Receptor Targeted Therapy RAD140 Next Gen Hormonal Therapies Phase 3 trial ✓ Build Capabilities ✓ *Oral SERD (Selective Estrogen Receptor Degrader)

Slide 20

Hormonal Monotherapy* Hormonal Combo Therapy Expected Trends 1L ~56K Pts Hormonal Therapy to Remain Treatment Backbone CDK 4/6i Combos to Become 1L SoC 2L ~33K Pts Hormonal Monotherapy in 2L and 3L to Increase after Prior 1L Combo Use 3L+ ~34K Pts Elacestrant Blockbuster Sales Potential as Mono and Combo Multi-billion Dollar Market Opportunity as Standard of Care (SoC) in Monotherapy and with Partner of Choice for Combination Therapy * The monotherapy use in 1L is dominated by AI class and 2L & 3L dominated by SERD class Source: NCCN Guidelines 2017; Physician Interviews; Clearview Healthcare Partners report; Ipsos Healthcare AI: Aromatase Inhibitor; CKD 4/6i: Cyclin Dependent Kinase Inhibitor; SERD: Selective Estrogen Receptor Degrader

Slide 21

Encouraging Elacestrant Clinical Trial Results *Results from Parts A-C; Median 3 prior lines of therapy ORR 2nd line SERD combo 2nd line mTOR combo 2nd line 3rd line 0 10 mo 19% Fulvestrant +Palbociclib (PALOMA-3) 9.5% Exemestane + Everolimus (BOLERO-2) 7-11% Fulvestrant (SOFEA, PALOMA-3) 2.1% Fulvestrant (BELLE-3) 1.7% Exemestane (BOLERO-2) 19% Fulvestrant +Palbociclib (PALOMA-3) 7.8 mo Exemestane + Everolimus (BOLERO-2) 4.6-4.8 mo Fulvestrant (PALOMA-3, SOFEA) 3.2 mo Exemestane (BOLERO-2) 1.8 mo Fulvestrant (BELLE-3) 0 20% 27.3% Elacestrant* (Phase 1; mono) 5.4 mo Elacestrant* (Phase 1; mono) Monotherapy Combination PFS Note: Because clinical studies are conducted under varying conditions and with different patient populations, information observed across studies may not be directly comparable

Slide 22

Elacestrant Phase 3 – Designed to Optimize Likelihood of Success Indication: 2nd and 3rd Line Patients with Prior CDK4/6i Use Study: Randomized Open Label Pivotal Study in ~460 patients with Advanced/Metastatic ER+/HER2- Breast Cancer Primary Endpoint: Progression Free Survival (PFS) PFS in All Patients*; PFS in Patients with ESR1 Mutations* Comparator Arm: Investigator Choice of Fulvestrant or an Aromatase Inhibitor Enrollment Timeline: 18-21 months Expected Data Readout: 2021 * Designed to allow testing in overall population (power of ≥90% for a hazard ratio of 0.667​) or ESR1-mut subset (power of ≥80% for a hazard ratio of 0.610​) at an overall α level of 5%, using Hochberg procedure Elacestrant (RAD1901) 400 mg PO QD Investigator Choice of Hormonal Agent Patient Population Patients with ER+/HER2- advanced/metastatic breast cancer Relapsed or progressed after 1 or 2 prior endocrine therapies Prior therapy with CDK4/6i required ≤ 1 prior chemotherapy for mBC permitted 1:1 Randomization Pioneering Clinical Development in a Post-CDK4/6i Setting

Slide 23

Elacestrant’s Potential to Change Treatment Paradigm Pivotal Clinical Trial Designed to Optimize Clinical Success Unmet Need Provide Single Agent Therapy Options after CDK4/6i Failure in 1st or 2nd Line 1 Responses post-CDK4/6i in Phase 1 Provide Alternative Therapies for Patients with ESR1 mutations 2 ESR1Mut and ESRwt Activity in Phase 1: 5 of 6 PRs in Patients with ESR1 Mutations Expand and Improve the SERD Class 3 Oral SERD with Differentiated Preclinical and Clinical Profile vs. Fulvestrant Provide Additional Hormonal Therapy Option to Defer Cytotoxic Chemotherapy 4 Favorable Tolerability Profile and Easy Administration Elacestrant

Slide 24

Elacestrant: Only Oral SERD in Phase III Phase 1 G1T48 AZD9496 (SERD) INVENTISBIO D-0502 SAR439859 GDC 9545 LSZ102 Phase 2 Phase 3 Elacestrant Oral SERD Development Landscape H3B-6545 (SERCA) Phase 1/2

Slide 25

Partnership Goals to Achieve Full Potential for Elacestrant Global Co-Development and Co-Promotion Partnership Seek Partner with a Global Footprint in Oncology Expansion into Earlier Lines and Combination Therapy Retain Strategic Value and Exploit Synergies with De-risked Program Maximize Success of Elacestrant and Value for Radius Shareholders

Slide 26

Active Early Stage Breast Cancer Product Pipeline Oral Selective Androgen Receptor Modulator (SARM) Evaluating for AR+/ER+ Metastatic Breast Cancer (~90% of ER+ BC Patients) Phase 1 Dose Escalation Ongoing Provisional MTD Identified and Being Further Tested Potential in other AR+ Oncology Indications Leverage Internal ER+ Expertise to Drive Next Generation Programs Potential in ER+ mBC and Other Oncology Indications Next Gen Hormonal Therapies RAD140 ✓ ✓

Slide 27

2 1 2019 and Beyond: Corporate Structure Lead and Transform Osteoporosis Treatment with Anabolics Provide Standard of Care in Hormonal Breast Cancer Leverage Operational and Financial Structure 3

Slide 28

Long-term Financial Growth Drives Value Creation $8 >$98 $155 - $175 USD in millions (TYMLOS Net Revenues) TYMLOS Sales Expected to Grow towards Market Leadership TYMLOS to Fund Near-Term R&D pipeline Lean Commercial Cost Structure * * Expected Net Sales

Slide 29

Leverage Existing Infrastructure to Support Oncology Current Structure Oncology Osteoporosis Synergies Support Regulatory and Clinical R&D Support Shift to Oncology Prepare and Support Launch Corporate G&A Leverage Existing Medical & Sales Partner and Build (n < 100 FTEs) Invest Post-Approval

Slide 30

2019 Milestones * Cash, cash equivalents and marketable securities Grow Full-Year Tymlos Net Sales to $155M to $175M Initiate Abalo-patch Phase 3 trial in Mid-2019 Advance Recruitment in Elacestrant Monotherapy Study Global Co-Development / Co-Commercialization Partnership for Elacestrant Initiate a Combination Trial for Elacestrant in Conjunction with a Strategic Partner Deliver a Strong Balance Sheet with >$100M Cash* Balance at Year-End

Slide 31

Q&A Session in the Sussex Room at 2:00pm