Press Release

Kala Pharmaceuticals Strengthens Commercial Organization in Preparation for First Product Launch

Headcount Expansion Further Bolsters Experienced Commercial Foundation

PDUFA Target Action Date for INVELTYS™ is August 24, 2018

WALTHAM, Mass.--(BUSINESS WIRE)--May 9, 2018-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of product candidates using its proprietary mucus-penetrating particle (MPP) technology, today announced the following key commercial hires in preparation for the potential approval and launch of INVELTYSTM, a twice-daily steroid eye drop in development for the treatment of inflammation and pain following ocular surgery:

  • Kathleen McCann Kline, Vice President of Marketing
  • James Patnoe, Vice President of Commercial Operations and Pricing
  • Carl Rennie, Executive Director of Account Management
  • Patrick Bedell, Executive Director of Trade and Alternate Channels
  • Lynette Zickl, Director of Commercial Analytics and Forecasting

“We are excited to welcome Kate, Jim, Carl, Pat and Lynette to Kala at such a pivotal time in our Company’s history. We believe that the collective talent, leadership and seasoned industry experience of our new team members will greatly advance Kala’s evolution into a commercial organization,” said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. “As we prepare for the potential approval and launch of INVELTYS, a product candidate that could be the first approved BID steroid eye drop for the treatment of inflammation and pain following ocular surgery, we will also continue to focus on advancing our other pipeline candidates, including KPI-121 0.25% for dry eye disease.”

Kala plans to continue growing its commercial organization in preparation for the launch of INVELTYS, including hiring its own specialty ophthalmology sales force pending the potential approval of the New Drug Application (NDA) for INVELTYS by the U.S. Food and Drug Administration (FDA). Kala’s NDA for INVELTYS was accepted for review by the FDA in January 2018 and given a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.

Kathleen McCann Kline, Vice President of Marketing
Ms. Kline has joined Kala Pharmaceuticals as Vice President of Marketing. Most recently, she served as Vice President of Marketing for the Ophthalmology and Women’s Health divisions at Bausch and Lomb where she was instrumental in leading the strategic initiatives supporting numerous surgical and pharmaceutical franchises, including intraocular lenses, surgical equipment and the Loteprednol franchise. Previously, Ms. Kline held Director and Product Manager positions at Allergan Pharmaceuticals where her focus was on their ophthalmology brands, including RESTASIS® and Refresh®.

James Patnoe, Vice President of Commercial Operations and Pricing
Mr. Patnoe has joined Kala Pharmaceuticals as Vice President of Commercial Operations and Pricing. Previously, he served as Vice President of Sales Operations, Contracts and Pricing at Takeda Pharmaceuticals America, where he spent 10 years in roles of increasing responsibility, including Vice President of Managed Markets. Formerly, he worked for TAP Pharmaceuticals and held various sales and leadership positions, including Vice President of Managed Markets, Director of Sales Operations and National Account Sales Director.

Carl Rennie, Executive Director of Account Management
Mr. Rennie has joined Kala Pharmaceuticals as Executive Director of Account Management. Prior to Kala, he was the Director of National Accounts for Collegium Pharmaceuticals. Previously, he worked for Sunovion Pharmaceuticals (Sepracor) as Executive Director of Payer Markets and National Director of Corporate Accounts. Mr. Rennie served in the United States Army Medical Service Corps.

Patrick Bedell, Executive Director of Trade and Alternate Channels
Mr. Bedell has joined Kala Pharmaceuticals as Executive Director of Trade and Alternate Channels. Most recently, he was Senior Director of Trade and Alternate Channels for Collegium Pharmaceuticals. Prior to Collegium, he worked in several commercial roles at Sunovion Pharmaceuticals (Sepracor), including Executive Director of Trade and Alternate Channels.

Lynette Zickl, Director of Commercial Analytics and Forecasting
Ms. Zickl has joined Kala Pharmaceuticals as Director of Commercial Analytics and Forecasting. Previously, she was Head of Insights and Analytics for scPharmaceuticals, where she led the Commercial Analytics and Operations build-out and helped the company transition from Series A to a publicly-traded company. Prior to scPharmaceuticals, she held commercial analytics roles at Shire and Cubist Pharmaceuticals.

About Kala Pharmaceuticals, Inc.
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYS™ (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which an NDA has been accepted for review by the FDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding the collective talent, leadership and seasoned industry experience of the Company’s new team greatly supporting the advancement of the Company’s evolution into a commercial organization, the potential approval and launch of INVELTYS, INVELTYS potentially being the first approved BID steroid eye drop for the treatment of inflammation and pain following ocular surgery, the Company’s continued to focus on advancing our other pipeline candidates, including KPI-121 0.25% for dry eye disease, and the Company’s plans to continue growing its commercial organization in preparation for the launch of INVELTYS, including hiring its own specialty ophthalmology sales force. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of various risks and uncertainties including, but not limited to: whether the data from our Phase 3 clinical trials of KPI-121 0.25% will warrant submission of an NDA on the timeline expected, or at all, whether any additional clinical trials will be required prior to submission of an NDA and whether any such NDA will be approved; whether our NDA for INVELTYS will be approved by its PDUFA date or at all; uncertainties inherent in the availability and timing of data from ongoing clinical trials; expectations for regulatory approvals to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company’s expected timeline; other matters that could affect the availability or commercial potential of the Company’s product candidates; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, discussed in the "Risk Factors" section of the Company’s most recently filed Annual Report on Form 10-K and other filings the Company makes with the Securities and Exchange Commission. These forward-looking statements represent the Company’s views as of the date of this release and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Source: Kala Pharmaceuticals, Inc.

Investor and Media Contact:
MacDougall Biomedical Communications
Cammy Duong, 781-591-3443
cduong@macbiocom.com