Optimizing success in cancer treatment
March 2020 | NASDAQ: BYSI
beyondspringpharma.com
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S | S | Assessing the Plinabulin opportunity |
D | I | |
A | ||
Q |
THE CURRENT CHEMOTHERAPY | THE UNMET NEED IN | THE POTENTIAL | HCP AND PAYER | GO-TO-MARKET |
LANDSCAPE | CHEMOTHERAPY-INDUCED | OF PLINABULIN | RESPONSE TO PLINABULIN | PLANS |
NEUTROPENIA (CIN) | PRODUCT PROFILE | |||
2
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B A Y S S D I A
Q
beyondspringpharma.com
The chemotherapy market gap
Healthcare professionals (HCPs) consider preventing CIN very important
to ensure patients receive the maximum benefit of chemotherapy1
MONOTHERAPY GRANULOCYTE-COLONY
STIMULATING FACTOR (G-CSF) DOESN'T ALLOW
FOR CHEMOTHERAPY OPTIMIZATION3
20182
CIN | BONE PAIN |
remains the #1 reason for | remains significant |
chemotherapy disruption2 | clinical issue3 |
2040
SLIGHT CHANGES IN DOSING OR DELIVERY CAN HAVE A DEVASTATING IMPACT ON SURVIVAL4
1A
MONOTHERAPY G-CSF IS SUBOPTIOMAL AND LEAVES A SIGNIFICANT CLINICAL GAP
PLINABULIN + G-CSF HAS POTENTIAL TO ADDRESS THIS IMPORTANT UNMET CLINICAL NEED
1. Proprietary market research, BYSI Summer/Fall 2019. 2. LaLami. 3. Moore. 4. Bonadonna G, Valagussa P, Moliterni A et al. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer. | 3 |
N Engl J Med 1995;332:901-906 |
CURRENT
CHEMOTHERAPY LANDSCAPE
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B A Y S S D I A
Q
beyondspringpharma.com
Significant opportunities exist to improve the standard of care
for patients on chemotherapy
Chemotherapy remains
THE CORNERSTONE OF TREATMENT
for most cancers
~650,000
U.S. PATIENTS
receive chemotherapy annually1
~1.3 MILLION CYCLES
of G-CSF used annually in the US
MYELOSUPPRESSION is currently an
unavoidable consequence of chemo that impacts patient safety and quality of life
Neutropenia and anemia
Chemotherapy dose delays and reductions
Risk of infection: G-CSF use, associated bone pain
Impaired anti-tumor immunity
Hospitalizations and unscheduled office visits
Red blood cell transfusions and erythropoiesis- stimulating agent rescue
Fatigue
Risk of bleeding: platelet transfusion
5
1. Centers for Disease Control and Prevention. Information for Health Care Providers. Available at: www.cdc.gov/cancer/preventinfections/providers.htm. Accessed February 21, 2020.
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S | S | 50%+ growth expected in use of first-line chemotherapy by 2040 |
Q | I | |
D | ||
A |
▪ The global chemotherapy market will continue to experience aggressive growth
- Globally new cases of cancer are expected to increase from 17M in 2018 to 26M in 2040
- First-line chemo patient growth: 53%
▪ More aggressive approaches, (e.g. Immuno-oncology + chemo will require improved CIN support)
▪ Plinabulin + G-CSF data demonstrate potential to support more aggressive chemotherapy with the potential for improved patient outcomes
Brooke E Wilson, Susannah Jacob, Mei Ling Yap, Jacques Ferlay, Freddie Bray, Michael B Barton; Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population- | 6 |
based study; www.thelancet.com/oncology Published online May 8, 2019 http://dx.doi.org/10.1016/S1470-2045(19)30163-9 1 |
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B A Y S S D I A
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beyondspringpharma.com
Treating CIN is an important priority for HCPs
HOW MUCH OF A PRIORITY IS TREATING CIN
IN RELATION TO OTHER COMPLICATIONS OF CHEMOTHERAPY?
Extreme Moderate Not at all
1%
23%
76%
7
QA08: In a patient's overall treatment plan, how much of a priority is treating CIN relative to other complications of chemotherapy (e.g. liver/renal toxicity, nausea/vomiting, anemia, etc.)?
beyondspringpharma.com
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A | Y | $7+ billion opportunity in CIN global market |
A | S | |
S | ||
D | I | |
Q | ||
Plinabulin can potentially be used with each cycle of G-CSF in chemotherapy to provide | ||
improved protection from neutropenia |
$5+B/yr:
THE US IS THE LARGEST MARKET FOR CIN
Plinabulin + G-CSF Addressable Market:
- US: 1.3M G-CSF cycles/year
- Global: 4M G-CSF cycles/year
CANADA | EU 5 |
AUSTRALIACHINA
SOUTH KOREA | JAPAN |
8
Note: 1 https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21338. G-CSF market growth based on IQVIA data (MIDAS for ex-U.S. and DDM MD for U.S.; Q3 '16 to Q2 '18. Standardized G-CSF units
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A | Y | G-CSF Biosimilars: Plinabulin commercial accelerators |
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D | I | |
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Combination therapy required to address unmet medical need
Biosimilar success coming at Amgen's expense
Aligns with Plinabulin's combination strategy
Market Share YE '191
- Increased choice
- Decrease price
- Biosimilar list price ~33% below branded
- Average selling price (ASP) continues to decline for all products
- The gap shows no sign of slowing
Current difference between branded and biosimilar ASP between $2,400 and $2,800/cycle
All trends favor Plinabulin's combination strategy
Neulasta Family (Amgen) | Fulphila (Mylan) |
Udenyca (Coherus) | Other |
1 shares approximate; not all G-CSF companies report market share performance 9
by product. Based on company filings and investor conference presentations
THE UNMET NEED
CHEMOTHERAPY WITHOUT COMPROMISE
- B A Y S S D I A
Q
beyondspringpharma.com
Unmet need not addressed by monotherapy G-CSF
Efficacy and safety of chemotherapy compromised by substandard care
Neulasta® after TAC for breast cancer
Efficacy | Neulasta 6.0 mg1 | Neulasta 6.0 mg2 | |||||
n=29 | n=61 | ||||||
Efficacy issue | |||||||
Neutropenia: | |||||||
Neutropenia (grade 3/4) | 96.6% | 100% | |||||
• | Grade 3 >0.5 & <1.0 | ||||||
Mean ANC nadir (109/L) | 0.255 ± 0.287 | 0.266 | |||||
• | Grade 4 >0.5 |
Neulasta after chemotherapy
Safety | Neulasta 6.0 mg3 | Neulasta 6.0 mg4 | ||
n=100 | ||||
Safety issue | ||||
Bone pain (score of 1-10) | 59% | 71% | ||
Severe bone pain (score of 6-10) | 24% | 27% | ||
Note: 1 Masuda N et al., Support Care Cancer 23: 2891-2898 (2015). 2 Lee J et al., Annals of Surgical Treatment and Research 94(5): 223-238 (2018). 3 Kirshner et al.,
Comm Onc 4:455-459 (2007). 4 Xu et al., Support Care Cancer 24:723-730 (2016). 5 Lalami et al., Critical Reviews in Oncology / Hematology 120 163-179 (2017). ). 6
O'Regan et al., Clinical Breast Cancer 6(2): 163-168 (2005). 7 Vasey et al., British J Cancer 87: 1072-78 (2002). 8 Alba et al. JCO 22(13): 2587-93 (2002).
Neulasta® is a registered trademark of Amgen, Inc.
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A | Y | Monotherapy G-CSF is not enough |
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Despite a broad use of monotherapy G-CSFs, the "4Ds" are a vexing clinical challenge for preventing neutropenia
DECREASED | DELAYED | DOWNGRADE | DISCONTINUED |
recommended dose | cycles | chemotherapy regimen | chemotherapy |
…CIN and/or febrile neutropenia may have long-term effects with clinical impact on the overall chemotherapy treatment plan, resulting in dose reductions and/or treatment delays, chemotherapy discontinuation, or a switch to less toxic alternatives, and potentially less effective regimens, leading finally to decreased response and survival rates.1
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1. Segal et al., 2008; Schwenglenks et al., 2006.
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A | Y | Maintaining dose and dosing schedules are critical for survival |
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DOSE REDUCTIONS = DECREASED OVERALL SURVIVAL1 | DELAYED CYCLES = DECREASED | |||||||
OVERALL SURVIVAL2 | ||||||||
BREAST CANCER | OVARIAN CANCER | |||||||
Dose reduction ≥15% (n=408) | Median years (95% Cl) | Dose reduction ≥15% (n=82) | Median years (95% Cl) | |||||
2.31 (1.87-2.87) | 2.30 (1.67-4.12) | |||||||
Dose reduction <15% (n=411) | Dose reduction <15% (n=88) | |||||||
3.67 (3.15-4.19) | 3.24 (3.00-NR) | |||||||
Log-rankP value | Log-rankP value | |||||||
0.0195 | 0.0114 | |||||||
. | 13 |
1 . 2. Chirivella I et al. Breast Cancer Res Treat. 2009;114:479-484
- B A Y S S D I A
Q
beyondspringpharma.com
Universal challenge of maintaining therapy
Dose reductions, delays, and missing doses by therapy (even with use of G-CSF)
16,000 patients
Despite broad-base use of monotherapy G-CSF, HCPs still struggle to deliver
▪ On time doses
▪ Full dose chemotherapy
▪ Full course chemotherapy
RESULT:
Chemotherapy is sub-optimized
HCPs recognize the clinical gap
STANDARD REGIMEN COHORT
14
Published, 2015. Per EMR review of 16,233 patients with 6 different tumor types 2007-2011.JNCCN-Journal of the National Comprehensive Cancer Network Volume 13 Number 11 November 2015.
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Q
beyondspringpharma.com
Compromised therapy: Quantifying the unmet market need
Shrink the Red
Breast; n = 10,435
Dose Reduction2
33%
67%
>= 15% < 15%
Dose Delay2
38%
62%
NSCLC; n = 609
Dose Reduction2
32%
68%
>= 15% < 15%
Dose Delay2
34%
66%
NHL; n = 1,852
Dose Reduction2
44%
56%
>= 15% < 15%
Dose Delay2
36%
64%
IMS PharmMetrics Plus™ study:
-
23% of Neulasta cycles were administered on days
other than the day after chemotherapy3 -
The study included over 200,000 Neulasta cycles from 2 patient databases. Approximately 14,000
cycles included Neulasta Onpro®3
>= 7 Days | < 7 Days | >= 7 Days | < 7 Days | >= 7 Days | < 7 Days | |
Note: 1Denduluri N, Patti DA, Wang Y, et al. Dose delays, dose reductions, and relative dose intensity in patients with cancer who received adjuvant or neoadjuvant chemotherapy in community oncology practices. J Natl Compr | ||||||
Netw. 2015;13(11):1383-1394.2 Based on planned regimen(95% CI). 3Retrospective cohort analysis based on health care claims from IMS PharMetrics Plus™ and Truven Health Analytics MarketScan® Commercial and Medicare | ||||||
Supplemental Databases. The collective data include health care claims from private US health plans, covering over 30 million persons annually. The data included all patients ≥ 18 years who, between July 1, 2010, and September | ||||||
30, 2015, initiated ≥ 1 course of myelosuppressive chemotherapy for a primary solid tumor or non-Hodgkin's lymphoma. All patients who received a selected chemotherapy regimen with a risk of FN and pegfilgrastim prophylaxis in | ||||||
≥ 1 cycles of chemotherapy were selected for inclusion in the study population. FN requiring inpatient care was identified based on an inpatient admission with a diagnosis (principal or secondary) of neutropenia, fever, or | 15 | |||||
infection using ICD-9 and ICD-10 codes. FN requiring outpatient care was only ascertained based on an encounter in the outpatient setting with a diagnosis of neutropenia, fever, or infection, and-on the same date-code for IV | ||||||
administration of antimicrobial therapy. |
beyondspringpharma.com
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A | Y | Monotherapy G-CSF unmet medical need - Summary |
A | S | |
S | ||
D | I | |
Q |
Severe neutropenia still at 96 - 100% even with the use of G-CSF for high risk chemo
Severe neutropenia causes RDI reductions
- RDI reductions = reduced survival
Bone pain is a significant challenge for patients
Monotherapy G-CSF does not have the potential to provide anti-cancer benefits
15% 50%
Reduction in Relative | Reduction in Overall |
Dose Intensity | Survival |
Clinical evidence indicates that dose reduction is
associated with decreased survival.
A more aggressive approach to CIN is needed.
Combination therapy with Plinabulin can address the
unmet clinical need.
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PLINABULIN
THE POTENTIAL TO ELEVATE THE STANDARD OF CARE
beyondspringpharma.com
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A | Y | Plinabulin sets a new standard of care |
A | S | |
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D | I | |
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Plinabulin + G-CSF has the potential to enhance chemotherapy care in the prevention of neutropenia | ||
Additionally, Plinabulin has demonstrated direct anti-cancer benefits in pre-clinical & clinical trials |
REDUCTION OF
SEVERE NEUTROPENIA
Combination prevents Grade 3/4
Neutropenia
82.00%
39% ↓
p = 0.03
50.00%
Peg 6 mg (n=21) Plin 20 mg + Peg 6 mg (n=16)
INCREASED RDI/
POTENTIAL FOR OS
Combination improves RDI: Percent of Patients >85% RDI
93.75%
80.95%
Peg 6 mg | Plin 20 mg + Peg 6 mg |
REDUCES BONE
PAIN
Combination reduces bone pain
100% | 95% | p < 0.0001 | |||||||
90% | |||||||||
80% | |||||||||
70% | |||||||||
of patients | 60% | ||||||||
50% | |||||||||
40% | 36% | p < 0.01 | |||||||
% | |||||||||
30% | |||||||||
20% | |||||||||
10% | 6% | 0% | |||||||
0% | |||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
At least X days of bone pain
Neulasta 6mg (n=22)
Plinabulin 20mg + Neulasta 6mg (n=16) 18
- B A Y S S D I A
Q
beyondspringpharma.com
Plinabulin has the power to transform the treatment journey
Chemotherapy Without Compromise
WITH LESS | WITH LESS | WITH HIGHER NADIR AND SHORTER | WITH NO |
GRADE 3 AND 4 CIN | BONE PAIN | DEJERINE-SOTTAS NEUROPATHY | THROMBOCYTOPENIA |
TODAY | WITH PLINABULIN | |||
DECREASED Doses | STABLE Doses | |||
DELAYED Cycles | SUSTAINED Cycles | |||
DOWNGRADE Regimen | STRONGEST Regimen | |||
DISCONTINUED Chemotherapy | STAY the Course | |||
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1. Data on file. BeyondSpring 2020.
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B A Y S S D I A
Q
beyondspringpharma.com
Plinabulin's broad indication presents a market-changing
opportunity
Plinabulin will be indicated for concurrent administration with a myelosuppressive
chemotherapeutic regimen in patients with non-myeloid malignancies for the prevention of CIN
PLINABULIN WILL BE USED WITH:
ALL G-CSFs | ALL CHEMOTHERAPIES | ALL CANCERS |
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PLINABULIN
MARKET RESEARCH FINDINGS
beyondspringpharma.com
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A | Y | Market Research Overview (Summer/Fall '19) |
A | S | |
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D | I | |
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PROJECT BACKGROUND
- BUSINESS NEEDS
- BeyondSpring is a US-based, global, clinical-stage biopharmaceutical company developing immuno-oncology therapies
- Plinabulin, currently in phase III clinical trials, will be used in combination with G-CSF therapies for the prevention of CIN
OBJECTIVES | METHODOLOGY | ||
▪ | Assess the potential access and | ▪ | Phase I - Qualitative Primary Market Research |
reimbursement landscape in the US | (National/Regional Payers, n=10) | ||
▪ | Provide purchaser and HCP perspective | ▪ | Phase II - Qualitative Primary Market Research |
on Plinabulin in the US | (Oncology Practice Managers/Purchasers, n=10) | ||
▪ | Understand how Plinabulin will be | ▪ | Phase III - Quantitative Primary Market Research |
incorporated into clinical practice | (Oncologists, n=110) | ||
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A | Y | Product differentiation: Target product profile |
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Indication: | Plinabulin is indicated for combination use with G-CSF for the prevention of CIN. Plinabulin is a novel, small molecule which acts in a more rapid fashion than standard of care CIN | ||||
High Risk CIN | therapies. Additionally, it has demonstrated anti-cancer properties. | ||||
Dosing & | Plinabulin: Administered by 30-minute IV infusion on the same day of chemotherapy | Pegfilgrastim (6 mg): Administered 24 hours after chemotherapy infusion either as a SQ | |||
Administration | administration. A single dose starts 30 minutes after chemotherapy infusion per cycle. | injection or an on-body device. A single dose of pegfilgrastim is given per chemotherapy cycle. | |||
Efficacy & | Plinabulin/pegfilgrastim (6 mg) combination is superior in both efficacy and safety to monotherapy pegfilgrastim (6 mg) | ||||
Safety | |||||
Study Design: Plinabulin/pegfilgrastim combination was evaluated for superiority vs monotherapy pegfilgrastim in patients who were randomized to receive chemotherapy and | |||||
Plinabulin/pegfilgrastim or chemotherapy and pegfilgrastim. Patients were monitored for 4 treatment cycles. All patients were provided best supportive care. | |||||
Plinabulin/pegfilgrastim (6 mg) combination | Pegfilgrastim (6 mg): | ||||
PREVENTION OF GRADE 4 NEUTROPENIA: | 40.9% | 62.5% | |||
Duration of Grade 3/4 CIN | 0.94 days | 1.38 days | |||
Efficacy | |||||
MEDIAN ANC NADIR | 1.00 | 0.47 | |||
(109 cells/L) | (>50% of patients avoid grade 3 and 4 neutropenia) | ||||
Chemotherapy benefits: | >90% | <85% | |||
• SUBJECTS MAINTAINING RDI >85% | |||||
6% | 12% | ||||
• Subjects with dose delays | |||||
Anti-cancer | Yes (NSCLC study) | No; pegfilgrastim is a growth factor | |||
Safety | Patients experienced more than 3 days of bone pain | 0% (P <.01) | 36% | ||
Neutrophil overshoot | 31% | 52% | |||
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A | Y | Oncologist's excitement for Plinabulin |
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D | I | |
Q | ||
Most important factors in choosing to use Plinabulin in | ||
combination with a G-CSF: |
15% | 50% | ||
Reduction in Relative | Reduction in | ||
Dose Intensity | Overall Survival | ||
Increase in median Absolute | Ability to maintain | ||
dose/regimen of | |||
Neutrophil Count (ANC) vs. | Reduction in bone pain | ||
chemotherapy | |||
monotherapy G-CSF | |||
Plinabulin's potential direct anti-cancer effect
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- B A Y S S D I A
Q
beyondspringpharma.com
Provider Positive excitement for combination therapy with
Plinabulin
Understanding of combination therapy: high
Likelihood to prescribe: high
RECEPTIVITY TOWARDS | LIKELIHOOD TO USE PLINABULIN + G-CSF |
COMBINATION THERAPY | COMBINATION THERAPY |
Favor mono | Low |
Tx | 10% |
9% |
No
Preference
17%
Moderate
25%
High | |
Favor to | 65% |
Strongly | |
favor | |
combination | |
74% |
QB04: On a scale of 1-9, where 1 = Not at all likely to use and 9 = Extremely likely to use, please rate your likelihood to use PLIN + G-CSF combination therapy | 25 |
QB01: How would you characterize the overall clinical benefit of PLIN vs. G-CSFs? |
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B A Y S S D I A
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beyondspringpharma.com
Payer market research: CIN Management
Economic results of CIN are more closely monitored; avoidance of cost - hospitalization - is paramount
Payers leave the decision of treatment modality to the HCP
Clinical Concern
- Infection
- Sepsis
- Febrile Neutropenia
Economic Concern
- ER visits
- Admission into hospital
- Prolonged hospitalization
- Readmission to the hospital
Research indicated that the most compelling attributes of Plinabulin were:
- Reduction in severe neutropenia
- Increase in Median ANC Nadir
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- B A Y S S D I A
Q
beyondspringpharma.com
Provider, patient & payer feedback summary
PATIENTS
- Cancer is the most stress inducing diagnosis
- Patients express a strong desire to follow the treatment plan and realize a good outcome
- Slight changes in the plan can cause great anxiety
- Patients want to stay the course
- Improved outcome and quality of life
PROVIDERS | PAYERS |
▪ | The majority of HCPs found the |
value proposition of the Plinabulin + | |
G-CSF combination compelling and | |
are highly likely to prescribe | |
▪ | Superior reduction in Grade 3 and 4 |
neutropenia vs. monotherapy G-CSF | |
▪ | Elimination of G-CSF-induced bone |
pain | |
▪ | Increase in Median ANC |
▪ | Potential reduction of infection and |
death |
CLEAR AND
COMPELLING RATIONALE
-
The product profile demonstrates significant value for payers to cover Plinabulin as an add-on to G-
CSF - Payers consider chemo and G-CSF- related complications to be purview of the HCP
- Reduced clinical concern
- Reduced cost
The potential for improved chemotherapy and improved overall survival | |
Chemotherapy Without Compromise | 27 |
PLINABULIN
GO-TO-MARKET IMPLICATIONS
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A | Y | Chemotherapy Without Compromise |
A | S | |
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D | I | |
Q | ||
Plinabulin's differentiated clinical profile andthe unmet market need enable us to pivot the discussion to | ||
improving the standard of care in chemotherapy |
DECREASED | DELAYED | DOWNGRADE | DISCONTINUED |
recommended dose | cycles | chemotherapy regimen | chemotherapy |
STABLE | SUSTAINED | STRONGEST | STAY THE |
DOSE | CYCLES | REGIMEN | COURSE |
maintaining >85% | cycles on time | of chemotherapy | complete all cycles |
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B A Y S S D I A
Q
CLINICAL GAP ANALYSIS
G-CSF monotherapy treatment gap
SCIENTIFIC PLATFORM
- Plinabulin performance
- Value proposition & message development
Congress activities & Peer reviewed publications
MARKET SHAPING
Extensive market research
Message resonance
- Engagement - Targeted customer interactions: KOLs, Payers, Patients
-
Speaker mobilization/Education:
• SOC short fall - 4Ds, 15/50 & OS - Reimbursement & coding preparation
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Key commercial actions
LAUNCH STRATEGY
- HCPs - 360⁰ Coverage
- Comprehensive commercial program
- Broad HCP & Payer coverage
- Patient support services to ensure ease of use, access and improve care
- Social media across all verticals
- U.S. manufacturing to guarantee supply
KEY MESSAGES:
- Combination therapy superiority
- Improved ANC & Reduced bone pain
- 4Ss - improved chemo flexibility
ACHIEVING IMPROVED CARE
Chemotherapy Without
Compromise
- Greater flexibility in delivering chemotherapy
- Improved clinical outcomes
- Superior market performance
SEASONED COMMERCIAL TEAM
- Complete commercial offering
- Broad coverage of providers, payers and patients across all channels
- Outstanding execution
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A | Y | Value proposition & Message development |
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SCIENTIFIC PLATFORM
- Reduction in:
- Grade 3 & 4 CIN
- Bone Pain
- Improvement in:
- Absolute Neutrophil Count (ANC)
- Compliance and persistency with chemotherapy
- Potential for:
- Greater flexibility in chemotherapy care
- Improved outcomes
- Prolonged Survival
GLOBAL SCALE
- Multi-nationaloperations
- World-wideclinical programs
- Chemotherapy induced neutropenia
- Non small cell lung cancer
- Scalable business model
- Manufacturing:
- Dynamic
- Robust
- Internationally balanced
- API and Drug Product
PATIENT CENTERED
- Clinical programs designed to provide clinically superior cancer care
- Combination approach is CIN focused on optimizing patient benefit and ease market entry
- Support programs designed to ensure access
- Education programs for Providers, Payers and Patients to drive understanding of differentiation and value
- tailored contracting for launch and long-term access & commercial success
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A | Y | Launch strategy: Provider, Payer, Patient |
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D | I | |
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Provider | Payer | Patient | |
• Promotion | • Access: | The Plinabulin Plus™ Patient Services | |
• HCPs - 360⁰ Coverage | • National, Regional & IDNs | Co-Pay Assistance Program | |
• High volume G-CSF users | • Targeted contracting | ||
• Will reduce out-of-pocket costs for | |||
- Top deciles & KOLs | • Ensure broad availability | ||
commercially1 insured patients | |||
- Top clinics/hospitals | |||
• Awareness, promotion and | |||
Patient Assistance Program (PAP) | |||
Reimbursement Support | contracting: National Account | ||
Managers | • Plinabulin will be provided at no cost to | ||
• | Coding and billing | ||
patients facing financial challenges who | |||
• | Dedicated field team | ||
• Education | meet program criteria2 | ||
• Education programs | • Peer-to-peer Programs | Alternative Funding Support | |
• On-line/in-person | |||
- Peer-to-peer;on-line/in-person | Plinabulin Plus™ work with patients to identify | ||
• CME | |||
- CME/Promotional | individual programs that provide financial | ||
• Promotional | |||
- MSL teams - clinical support | support through independent organization and | ||
• MSL teams - clinical support | foundations | ||
Peer Reviewed Publications | |||
1 | Medicare, Medicaid and Federal/state program patients will not be eligible for the commercial co-pay program | 32 |
2 | The Patient Assistance Program will not cover the costs related to Plinabulin infusion |
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B A Y S S D I A
Q
beyondspringpharma.com
Seasoned commercial team delivering an improved standard
of care; improving chemotherapy
Seasoned leadership team
Experienced in building/scaling organizations and successfully launch products
- Deep oncology experience
- 15+ years of Part B experience
- Multiple specialty and oncology launches
Planning for the Plinabulin launch for over a year
On-going partnership discussions in all major markets
Executed broad-based market research and HCP outreach
Initiated core KOL team identification and buildout
Pre-launch Support
- Key Account managers
- Medical Science Liaisons
- Advisory Boards
Launch Support
- 60 Oncology Account Managers
- 6 Regional Sales Directors
- 6 Key Account Managers
- 6 Field Reimbursement Liaisons
- 7 Medical Scientific Liaisons
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A | Y | P&L strength enables "go-it-alone" potential in US |
A | ||
S | S | |
D | I | |
Q | EU is ideal for partnership | |
US market dynamics
US Strategy | Europe Strategy | |
Of the that 14 launched in the US… | • Of these launches, we have evidence that 11 | |
subsequently | launched in Europe, choosing to… | |
and P&L strength | Go-It-Alone | Co-Promote | Go-It-Alone | Out-License | ||||||
provide | 71% | 29% | 27% | 73% | ||||||
n = 10 | n = 4 | n = 3 | n = 8 | |||||||
BeyondSpring with excellent leverage for partnership
Source: ZS analysis; ZEJULA ex-US rights to Takeda and VARUBI US and Canada rights to TerSera. (3) Post-launch, Ariad sold ex-US rights to Incyte prior to | 34 |
Source: Evaluate Pharma as accessed on February 25th, 2019 and company press releases |
beyondspringpharma.com
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B A Y S S D I A
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Commercial
A growing market
40% increase in | Biosimilars: |
chemo cycles by | increase |
20401 | choice, decrease |
price2 |
Plinabulin success drivers
Clinical
Improving standard of care
4S | Drive | Anti- | Decrease | Improve |
Stable dose, | therapy | cancer | in bone | clinical |
Sustained Cycles, | for cure4 | benefits5 | pain6 | flow3 |
Strongest Regimen, | ||||
Stay the Course3 |
1 Wilson B Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population-based study 2 Coherus/Mylan biosimilars priced at a 33%; Sandoz biosimilar priced at a 37%
discount to Amgen's Neulasta (company press releases); ASP has continued to fall for biosimilars since launch (Redbook, CMS, Bernstein analysis) 3 Lalami Y Impact of CIN and FN on cancer treatment outcome: An overview about well- | |
established and recently emerging clinical data 4 BYSI primary market research 5 Plinabulin P2 study results 6 Blayney, Douglas, et al, Plinabulin, a Novel Small Molecule in Development for Chemotherapy-Induced-Neutropenia (CIN) | 35 |
Prevention, Mobilizes CD34+ Cells through a Mechanism of Action Different from G-CSF and from CXCR4 Inhibition, ASH '18 3 Lalami Y Impact of CIN and FN on cancer treatment outcome: An overview about well-established and recently |
emerging clinical data
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BeyondSpring Inc. published this content on 17 March 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 March 2020 19:54:02 UTC