Xeris Pharmaceuticals

A CASE STUDY

As companies experience significant growth and hit major milestones in their evolution, they often need to re-evaluate their existing processes and determine whether the way they’ve been operating is sustainable, or if changes are needed. A company going public without a doubt qualifies as a milestone that would lead to this evaluation, not to mention all of the additional requirements and restrictions that come with being a public company. A pharmaceutical company receiving FDA approval for one of their products is another milestone that would lead to an examination of internal policies and procedures.

Xeris Pharmaceuticals experienced both of these scenarios above in a span of just over a year. During this remarkable phase of growth, the volume and scrutiny of Xeris’ corporate agreements would increase exponentially, leading to the need for a more sophisticated system for managing these contracts and the data held within them.

ContractWorks partnered with Xeris to provide a contract management solution that enabled them to track contract milestones, tighten internal controls around contract execution, and easily report on contract data to provide increased insight to key stakeholders throughout the company, all helping to demonstrate compliance with industry regulations.

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Overview

Headquartered in Chicago, Illinois, Xeris (Nasdaq: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, GvokeTM. Its proprietary XeriSolTM and XeriJectTM formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Before implementing ContractWorks, Xeris did not have a formal contract management process in place. Contracts were split between physical folders and shared drives, and were loosely tracked on a spreadsheet, making it next to impossible to manage a rapidly growing contract portfolio and related deadlines. Xeris also knew they needed to tighten their protocols and implement additional safeguards into their contracting process as they grew.

And after going public in 2018, the compliance and regulatory requirements Xeris had to comply with ramped up drastically. To prepare for this next phase of the company’s evolution, Xeris needed to ensure that they had the tools and processes in place to stay organized and demonstrate that the internal controls and delegation of authority were being followed. ContractWorks provided the Xeris team with a solution to accomplish these contract management goals and more.

“Implementation was easy with ContractWorks. I had a ton of PDFs and I was able to just drag and drop them into the system. I just ran a report and found that so far this year I’ve implemented over 1,200 contracts.”

Adrienne Foster

Contracts Manager, Xeris Pharmaceuticals, Inc.

Challenges

Growing companies reach a point in their lifecycle when the existing ways of tracking, routing, and signing corporate documents no longer make sense. The volume of high-risk contracts quickly increases, along with the repercussions of not effectively managing those agreements and their deadlines and deliverables. With Xeris preparing to go public while working to gain approval on their first FDA-approved product, it was clear their contract portfolio was about to take off - and it did. The team at Xeris needed to add structure to their contract management process to help with contract visibility, reporting, and compliance.

  • Struggled to keep track of where contracts were in the signing process and stay ahead of deadlines for the thousands of active contracts in their portfolio
  • The shift from a private to a public company increased the need for contract visibility and insight into corporate agreements, as well as internal compliance with various regulations like the Sunshine Act and Insider Trading regulations
  • Every Xeris employee needs to sign numerous policy documents throughout the year to demonstrate compliance with industry regulations, and the number of employees is growing rapidly
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Results

Since implementing ContractWorks, Xeris has greatly improved their contracting protocols and now has a system in place to help demonstrate compliance with regulations, including the Sunshine Act, Insider Trading regulations, and more. Xeris now manages over 6,000 contracts, a near-impossible task without dedicated contract management software. And while it started as simply a contract repository, Adrienne now routes all contracts that need internal sign-off through the ContractWorks platform using the built-in electronic signature tool, routes vendor contracts for signature, runs reports to provide various department leaders with insights into key contract details like the contract’s owner, dollar amount, effective date, and expiration date, and has automatic processes in place to notify the appropriate managers when company policy documents have been signed.

  • Provided a system for sending, e-signing, and routing internal policy documents that need to be signed by each new employee

“We just hired 63 sales reps and we had to send each of them five separate policy documents to sign in one day. ContractWorks helped me get the job done.”

  • Improved contract reporting capabilities and gave department heads insight into their most important contracts

“I run quarterly reports for the business managers to show that these departments have executed these contracts, and the business manager can see who the business owner is, the dollar amount, the effective date, and expiration date for each contract. I also run a report for our training department so they know when employees have signed off on their policies so they can keep that information in their HR files.”

  • Added efficiency and visibility to the contract signing process

“Every contract has to be reviewed and signed internally by the department manager, the Legal reviewer, and the Finance reviewer, which typically happens in about five days. The built-in e-sign tool makes things easy for me because I can see where a contract is in the signing process.”

  • Helped tighten internal controls and add structure and safeguards to the contracting process

“It’s made a huge impact for Finance. Before, people were getting contracts reviewed and approved legally, but not having the financial controls necessarily approved. Our new process using ContractWorks saves time and it also tightens the financial controls because they know that the contracts don’t go out unless 1. Finance has approved it and 2. a purchase order has been issued.”

  • Provided a way to track and demonstrate compliance with industry regulations
“When we hire someone, we have to attest to the fact that they’ve been trained on certain policies within a certain timeframe. I send out the policies and when I set up the templates, I add the business owner so they’ll automatically get a report as soon as the person has completed the training. My next project is to start sending out quarterly attestations to our Sales reps to e-sign to confirm they haven’t violated the Sunshine Act and that all of the expenses they’ve submitted are in compliance.”

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