In an industry where CEOs rise and fall on the outcomes of their clinical trials, Megan Baldwin is still ascending.

Baldwin, CEO of ophthalmology biotech Opthea (ASX:OPT), became a famous name in biotech last year after the company leapt from a $200m tiddler to $1bn behemoth overnight.

She’s been described as ruthless, a natural CEO, a steady hand, driven, likeable, a perfectionist, and controlling.

In person Baldwin is engaging and direct, with an ability to recall details of deals and people from years ago.

But as the myth around her builds, the woman who six years ago shook up a tired biotech company says she just followed the science.


The myth of the scientist CEO

Baldwin is the CEO whose PhD work turned into a multi-billion dollar drug candidate, or so the story goes.

She was one of a group of Melbourne researchers in the late 1990s who were working on a newly discovered protein: the VEGF molecule — vascular endothelial growth factor — which causes blood vessels to grow and leak.

The work to commercialise VGEF in Australia ground on after Baldwin left in 2001, joining Genentech in San Francisco (the company which snared VEGF discoverer Napoleone Farrara).

Then in 2006 the molecule was picked up by Circadian CEO Robert Klupacs, who bought the development rights from the Ludwig Institute for Cancer Research. The institute’s boss — Baldwin’s old supervisor Marc Achen — suggested Klupacs get in touch.

Baldwin was looking for a way to come home; Klupacs had intellectual property she was familiar with; and so the story of the CEO who attended the birth of the molecule she’d one day turn into a drug was born.


Trial by fire

The ASX was introduced to Baldwin in 2014.

It would not be a comfortable beginning for anyone.

The Circadian board had a difficult relationship with Klupacs, who it dumped in December 2013.

Baldwin was anointed in February the following year and launched a complete review of the company’s programs: the lead drug for cancer which was showing promising results in a phase 1 trial, a diagnostic technology, and a pre-clinical treatment for wet age-related macular degeneration (wet-AMD) using VEGF-C.

Clinical trials are generally divided into three phases. Phase 1 focuses on safety, phase 2 tests for effectiveness and phase 3 examines whether the new drug is an improvement on existing treatment. Sometimes trials are further divided into parts A and B, where a B stage is generally more rigorous

What she did next, as clickbait headlines say, shocked everyone.

Baldwin dropped the cancer program, despite the promising clinical data and money already spent getting there, and prioritised the early stage pre-clinical wet-AMD treatment.

“It was a massive decision because we were taking a step back,” she said.

“But it was a reflection of the fact that ophthalmology and the AMD and DME (diabetic macular edema) landscape was less competitive, and the fact that the molecule that we could move forward in ophthalmology was superior [to the cancer therapy].

“I had a lot of confidence that we were doing the right thing.”

But she had to persuade the board, which was stuck on cancer, furious shareholders who’d been around since the company’s inception in 1985, and investors who’d be needed to fund the expensive path ahead.

Klupacs says Baldwin’s likeability was key to bringing those groups on board; it was her “ruthlessness” in knowing what needed to be done to get the drug through clinical trials that did the rest.

Others were happy to back her data, if not her judgement. Some labelled Baldwin, then 39, a “green” CEO. This still bugs her, the irritation in her voice palpable as we discuss the young male peers who didn’t earn the same review.

Lawrence Gozlan, founder of Scientia Capital, was one of the few Australian investors to back Baldwin’s vision; he said she was nervous about stepping in as CEO.

“Megan had crafted this strategy and I think boards are willing to listen to investors when they’re low on cash,” he said.

“But where Megan stands above the rest, she has delivered a clinical trial with excellence, in terms of recruiting patients faster and getting results out sooner.”

A perfectionist nature is what has enabled her to deliver clinical trials on time and under budget, rather than the unspoken “add 12 months [to a trial timeline] and an extra 50 per cent [to the budget]” rule, says Gozlan.

“For someone who is custodian of my capital and determining where to allocate the capital that we’ve provided, you want someone like that. You don’t want someone who is flippant with cash.”

Baldwin describes it as staying out of the way but across the detail, meaning she knows exactly what is going on in the nine-person company but isn’t in the lab telling people what to do.


Behind every great woman…

Baldwin stands out all the more because of her gender.

Biotech is an industry that doesn’t lack female CEOs, but she readily admits that there aren’t many senior women in the sector.

“Some of the attrition is going to be a natural attrition from women taking some time out to pursue family endeavours and they should have the right to do that, and I think there’s a lot more mechanisms now for them to do that alongside their career,” she said.

“I don’t think I’m necessarily different but I think I was always driven to have a career.

Baldwin has two children and a “fantastic husband” who is a senior scientist at CSL.

It’s a relationship based on reciprocity: they both recognise the importance of each other’s career and have a family “framework” to enable both to travel and work irregular hours. They have a policy never to both be travelling overseas at the same time.

“I do firmly believe that it’s important for women and men to have a career or something that really motivates them. I enjoy having that level of independence that is separate to what my husband’s doing… I couldn’t imagine not having that in my life.”


Is she rocket woman or Icharus?

Opthea produced an excellent result from its phase 2b wet-AMD trial last year, as reported by Stockhead, for which Baldwin received considerable credit.

The next step is a phase 3 trial: a $150m-plus year long event likely to involve two trials of about 400 patients each.

It’s not unheard of for drugs to pass phase 2 trials and fail at phase 3. In 2018 alone several apparently promising drugs for Alzheimer’s, asthma, acne, tinnitus, cancer and brain aneurysms failed at the final hurdle.

But ASX investors are now backing Opthea like the race is won.

Baldwin’s supporters say she chose the right technology, the right market, and carefully shepherded the company through the rigours of clinical trials faster than expected and under budget.

Her detractors say many hands contributed to the success of OPT-302 and she is lucky — had the trial last year failed she would not be being feted as the biotech star she is today.

Baldwin just says she just followed the right science.