Clinical Trial Results and a Leadership Change

This week our biotech pick Theravance Biopharma (Nasdaq: TBPH) announced the results of its 12-month long Phase 3 study of revefenacin (TD-4208), jointly conducted with Mylan (Nasdaq: MYL). As we discussed in the June 9 weekly issue, the results released earlier this year from the first two Phase 3 studies for revefenacin were good, and the results of this third study are similarly strong.

1055 patients with COPD (Chronic Obstructive Pulmonary Disease) were studied over the course of 12 months to test the safety of revefenacin as a once-daily nebulized treatment. The drug was generally well-tolerated, and no new safety issues were identified. Furthermore, the rates of serious side effects were low and comparable to those in the control group, who received standard-care treatment—Spiriva, a hand-held inhaler.

A nebulizer differs from an inhaler in that the machine is electric- or battery-powered and the patient only has to place a mouthpiece in his/her mouth or a mask over his/her mouth and nose in order to consume the medicine in mist form. Inhalers require a little more work and sometimes—especially true for children and the elderly—inhaling the medicine properly can be tricky.

In conjunction with the previous phase 3 studies on revefenacin, which demonstrated superior efficacy compared to placebo, the latest results provide Theravance and Mylan with enough data to file a New Drug Application with the FDA, anticipated in the fourth quarter this year. The standard review period is 12 months (or less) from the date of submission, so assuming approval the new drug will likely be on the market by the beginning of 2019.

Lindsay Corporation (NYSE: LNN) has named Tim Hassinger as new President and CEO, effective October 16. He will replace the retiring Rick Parod, who had led Lindsay since 2000.

Hassinger, 55, is the President and CEO of Dow AgroSciences, a subsidiary of Dow Chemical (NYSE: DOW). He has been CEO only since 2014 but has spent thirty-three years with Dow. He began his Dow career out of college as a sales trainee, held a number of management positions, and eventually reached the pinnacle of CEO.

Interestingly Hassinger has experience working in China, where he served as Regional Commercial Unit Leader for Greater China for 19 months, and he had seven years of experience leading agricultural business units in Latin America and other developing regions. We expect China and other developing countries to be Lindsay’s highest-growth regions, so the new CEO’s experience working in the country is a positive.

Lindsay’s Chairman of the Board had this to say:

“The board unanimously agrees that Tim is the right choice to lead this great company into the future. He brings global business experience with an exceptional track record of business leadership and creating profitable growth. This, combined with his people and customer focused operating style, has fueled his ability to exceed customer expectations and consistently deliver strong financial results.”

Parod has done a good job of guiding the company through a difficult macro environment for agricultural companies over the past few years. But he hasn’t been able to overcome the industry headwinds and the company has pretty much just tread water. We will watch with keen interest if Hassinger has any plans up his sleeve to add some juice to the company’s growth profile.

Also this week, Lindsay declared a $0.01 cent increase to its quarterly dividend. This ups the quarterly payout to $0.30 per share (or $1.20 per share per year). The current yield is 1.28 percent. While we don’t think of Lindsay as an income stock, over the past three years, it has raised its dividend at an annual rate of 14 percent, although the figure is skewed by a one-time 100 percent increase in 2013, during a very favorable period for Lindsay. Looking ahead, at least until crops enter an extended bull market, we expect the company to stay with the policy it has implemented in the last several years of increasing the quarterly dividend by $0.01 per year, which would put the annual dividend growth rate in the 3 percent range.

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