Biotech in 2016 and the Year Ahead with TheStreet’s Adam Feuerstein

Episode Summary

Executive Summary: Adam Feuerstein reviewed 2016 as a difficult year for biotech, marked by stock weakness, high uncertainty, and more failures than breakthroughs. He discussed controversial FDA decisions like Sarepta’s Exondys approval, the Theranos collapse, the lack of major drug approvals, persistent skepticism around Alzheimer’s drugs, the promise of cancer immunotherapy combinations, and whether Gilead and other big biotechs need strategic changes entering 2017.

Main Topics: 2016 as a weak year for biotech (Priority: 5/5): Feuerstein characterized 2016 as broadly bad for biotech, especially for stocks, because of drug-pricing fears, policy uncertainty, and a lack of major positive catalysts. Controversial FDA approval of Sarepta's Exondys (Priority: 5/5): He argued Ed K. (Sarepta) earned recognition for getting a difficult Duchenne drug approval through, while acknowledging the approval remains controversial and may not set precedent. Theranos and the limits of Silicon Valley thinking (Priority: 5/5): Elizabeth Holmes was singled out as the worst CEO because Theranos was presented as a revolutionary diagnostics company but ultimately appeared to lack real substance and conceal operational problems. Alzheimer's drug setbacks and Biogen's prospects (Priority: 4/5): After Lilly’s failure, the field remains skeptical, but Biogen’s drug still has a scientific rationale and the debate will continue until more definitive data arrive. Cancer immunotherapy combinations as a major 2017 theme (Priority: 4/5): Feuerstein expected the field to move beyond monotherapies and focus on combination regimens, especially in lung cancer, to broaden response rates. Gilead's growth challenge and need for M&A (Priority: 4/5): He said Gilead’s core HIV/hepatitis C business is no longer enough and that investors will continue pressuring the company to make an acquisition or show a new path to growth. Leadership turnover at big biotechs (Priority: 3/5): Biogen’s internal CEO promotion and Alexion’s leadership opening were framed as signs of a broader biotech management shakeup that could reflect strategic uncertainty.

Key Arguments: Biotech entered 2017 with significant uncertainty around regulation, drug pricing, and the new U.S. administration, which is harmful for stock performance. Sarepta’s FDA approval was controversial, but the CEO deserved credit for executing a difficult regulatory path and getting a drug to patients. The FDA’s Exondys decision may be treated as a one-off rather than a new standard, so it should not automatically broaden approval expectations for other companies. Theranos succeeded for so long because of prestige, fundraising, and Silicon Valley hype, but the episode shows that health care and science are not easily solved by software-style disruption. 2016 had fewer standout drug approvals and more visible setbacks, though annual approval counts naturally fluctuate based on timing. Alzheimer’s remains scientifically and commercially attractive despite repeated failures because the unmet need is so large; Biogen’s program still has a plausible case. Cancer immunotherapy will remain central, but the next wave is combination therapy aimed at increasing response rates beyond the current minority of responders. Gilead faces a classic post-growth problem: its hepatitis C success created high expectations, but internal pipeline weakness makes M&A the likely route to renewed growth.

Data Points: Year discussed: 2016 - The interview reviewed the biotech year that was and looked ahead to 2017. FDA approval year for Sarepta's Exondys: 2016 - Sarepta received a controversial approval for its Duchenne muscular dystrophy drug. Expected timing for definitive Biogen Alzheimer’s data: 2018 at the earliest - Feuerstein said the debate over Biogen’s Alzheimer’s drug would continue until more data arrive. Number of prominent cancer immunotherapy companies mentioned: 4 - AstraZeneca, Roche, Merck, and Bristol-Myers were cited as key players in combination therapy development. Annual conference referenced: 17th Annual Outsourcing and Clinical Trials New England 2025 Conference - Mentioned in sponsor copy before the interview. Biogen leadership change: Internal candidate promoted to CEO - The company chose its chief commercial officer as CEO. J.P. Morgan Healthcare Conference timing: Annual January meeting - Used as the key industry event where expectations and news flow matter.

Pivotal Quotes: "I think it really is kind of remains to be seen is probably what we have to... the best thing to say." — Adam Feuerstein: On whether the Exondys FDA approval will change future regulatory behavior. "Science is hard." — Adam Feuerstein: On why Theranos failed and why health care is not like consumer tech disruption. "We’re sort of coming out of this pretty horrible year." — Adam Feuerstein: On the state of biotech entering 2017 and why expectations were low.

Implications: Listeners should expect 2017 to be shaped by policy uncertainty, continued pressure on drug pricing, and a search for real growth stories. Winners may be companies with strong clinical data, combination immunotherapy strategies, or credible M&A plans.