Pharmaceutical and Biotech Gross-to-Net Conference

October 16-17, 2019 | Chicago, IL

HGI Chicago Downtown Magnificent Mile

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DAY ONE | WEDNESDAY, OCTOBER 16

7:45 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Paula Martins, Director, Commercial Contacts & Operations, AMNEAL PHARMACEUTICALS

8:45 PANEL: OVERCOMING CHALLENGES IN ACCURATE GROSS-TO-NET FORECASTING
As financial operations within pharmaceutical and biotechnology industries continue to evolve, organizations must establish greater accuracy when estimating realistic gross-to-net calculations while mitigating significant forecasting challenges. Finance leaders at diverse pharmaceutical and biotechnology corporations must assess opportunities for developing new forecast strategies as well as expand upon current GTN strategies according to specific needs. By assessing current and evolving policy changes, challenges with external partnerships, and employing innovative data and analysis tools, finance executives will be able to optimize forecasting strategy and ensure successful GTN management.

  • Strategies for estimating market changes
  • Blending short and long-term forecasts
  • Enhanced data automation processes

MODERATOR: Stephen Ruscus, MORGAN, LEWIS & BOCKIUS LLP

PANELISTS: Michele Cardone, NOVARTIS

Larry Breen, SUNOVION

 

9:30 MASTERCLASS: PHARMACEUTICAL RETAIL PIPELINE & IMPACT ON ACCRUAL CALCULATIONS
Pharmaceutical and biotechnology corporations face one of the most challenging retail pipelines, creating considerable difficulty in accurately forecasting revenue based on product utilization, prescribing habits, as well as intricacies surrounding net revenue, whether generated from wholesalers & distributors, payers or patients individually. Chargebacks, rebates and restricted payments from payers create an additional level of complexity and must also be accurately balanced and positioned within income statements. Understanding the current retail environment for pharmaceutical and biotechnology products, impact of health policy and legislation on pricing and contracting, and the overall impact of external forces on financial accounting is essential for the forward thinking finance & accounting executive.

Larry Breen, Director of Financial Planning & Analysis, SUNOVION

 

10:15 COFFEE & NETWORKING BREAK

 

10:45 ANALYZING THE FINANCIAL IMPACT OF HEALTH POLICY CHANGES
To address current legislative changes and prepare for projected developments, pharmaceutical and biotechnology finance leaders must align CMS rebate regulations with pricing and coverage gap changes to ensure accuracy and a reduced impact on gross-to-net calculations. Increased certainty is necessary as forecasts are projected earlier and finance teams make predictions that are impacted by market fluctuations, changes to Medicare parts B and D and Medicaid agreements. Beyond difficulties with national policy changes, the lack of data accuracy at the state level is also concerning which, coupled with payment delays, auditing challenges, and the impact of accrual adjustments, creates concerns that finance teams must mitigate.

Stephen Ruscus, Partner, MORGAN, LEWIS & BOCKIUS LLP

 

11:30 PANEL: IMPACT OF GOVERNMENT LEGISLATION ON PHARMACEUTICAL PRICING & GTN MODELING
A wide variety of legislative proposals and new regulatory frameworks currently being considered by the US government, including revisions to Medicare parts B and D, reduction or elimination in rebate programs as well as alteration of safe harbor rules would each have a significant impact on current gross-to-net forecasts, as well as modeling of net revenue for the future. While a certain level of uncertainty is always present when making such forecasts, current proposals would have considerable impact on forecasts and would require a heightened level of flexibility within forecasts. Beyond current legislative action, the 2020 presidential election along with candidate promises such as “Medicare for all” have executives from industry facing a continued level of uncertainty.

PANELISTS: Paula Martins, AMNEAL PHARMACEUTICALS

Earl Kiesel, DAIICHI SANKYO, INC.

Thomas Moser, NOVARTIS

Michele Cardone, NOVARTIS

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 WORKSHOP: SCENARIO PLANNING GTN FORECASTS AMID REGULATORY CHANGES & UNCERTAINTY
Although regulatory changes and legislative action are impossible to predict with complete certainty, finance executives must consider practical approaches to forecasting the impact that changes will have to net revenue calculations. Having an opportunity to discuss in small groups potential revenue forecasts based on varied scenarios will provide participants with practical, hands-on experience in handling uncertainty, as well as learning directly from attendees, who bring varied approaches to interpreting and implementing potential changes.

WORKSHOP OBJECTIVES:

  • Review distributed scenario as a group
  • Discuss short & long-term impact on GTN
  • Prepare summary of decisions & process
  • Report back to the larger group & discuss

Paula Martins, AMNEAL PHARMACEUTICALS

Michele Cardone, NOVARTIS

 

2:30 INTEGRATING REBATES INTO GROSS-TO-NET CALCULATIONS, FORECASTS AND REVENUE STATEMENTS
The use of product rebates within the pharmaceutical and biotechnology industry has become a common business practice, creating an additional and oftentimes substantial line item impacting accrued revenue. Although much discussion is currently focused on the elimination or reduction in rebates, or the payment of rebates directly to consumers, finance and accounting executives must continue to accurately forecast and accrue for contracted rebates.

  • Generating data to support rebate accuracy
  • Variability in rebate utilization & documentation
    • Government payers
    • Private payers & PBMs
    • Patients
  • Future considerations for rebate accruals

Francis Ruffy, Director Revenue & Profitability Insights, PWC

 

3:15 COFFEE & NETWORKING BREAK

 

3:45 ACCURACY IN FORECASTING GTN REVENUE FROM PHARMACY BENEFIT MANAGEMENT AGREEMENTS

  • Assessment of revenue generated from PBM contracts
  • Impact of PBM contracts on long-term revenue forecasts
  • Balancing payments & accurately integrating rebates
  • Potential changes to revenue based on regulatory action

PART ONE: INDUSTRY PERSPECTIVE:
Thomas Bogle, Director, PWC

 

4:15 PART TWO: ECONOMIST PERSPECTIVE:
Joseph P. Fuhr Jr., Professor Emeritus of Economics, WIDENER UNIVERSITY

 

4:45 USE OF ACCRUALS ACCOUNTING IN GTN: BALANCING REVENUE AGAINST REBATES & CHARGEBACKS
In order to accurately report current net revenue, as well as forecast future revenue, accruals based accounting is used to provide leadership with a realistic and current projection of revenues, reflective of deductions such as chargebacks and rebates provided to external partners. Analysis of various balance sheets exhibiting how accruals have been accurately portrayed will provide participants with greater knowledge of this intricate process, as well as best practices used by leading corporations.

Sal Mannarino, Managing Director – Life Sciences & Healthcare, Transaction Advisory Services
ERNST & YOUNG LLP

 

5:30 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on October 16th. Please note that dinner expenses must be covered by each participant individually.