Eiger BioPharmaceuticals: The Results Are In - The CEO And The CFO Are Out

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This is my first look astatine Eiger (NASDAQ:EIGR) an absorbing Biotech that is sailing successful stormy seas.

Eiger reported its overmuch anticipated shape 3 results correct connected time.

Then CEO Cory opened its Q3, 2022 net telephone (the "Call") connected 11/03/2022 pinch bold statements astir its precocious pipeline. He enthused astir aggregate precocious shape breakthrough therapy designated programs. At nan apex, wrong weeks, Eiger was connected target to study topline information from nan Phase 3 D-LIVR study of 2 different Lonafarnib based regimens for nan curen of HDV.

He described nan study's ample scale, nan largest HDV study ever. It included 400 patients enrolled crossed 100 sites successful complete 20 countries. The impending readout would beryllium a notable milestone for some Eiger and patients suffering from HDV.

He characterized HDV arsenic nan astir terrible shape of viral hepatitis. It impacts 12 cardinal group globally and location is nary FDA approved therapy. Of people erstwhile 1 hears "hepatitis", Gilead (GILD) nan institution that conquered HCV comes to mind.

Its caller BLA for its HDV therapy, bulevirtide, received a 10/2022 CRL. The CRL cited concerns regarding nan manufacture and transportation of bulevirtide. It did not require immoderate caller study connected information aliases efficacy.

Gilead surely has nan resources and nan knowledge to threat to attraction connected correcting immoderate deficiencies. However this rumor was not mentioned successful immoderate of nan pursuing caller Gilead reports, its:

1. Q4 2022 Earnings Call Transcript;
2. Q4 2022 Earnings Call Presentation; or
3. 02/14/23 information successful SVB Securities Global Biopharma Conference.

HDV is simply a large woody for Eiger; for Gilead its bulevirtide CRL does not look to beryllium a privilege issue. Notably, bulevirtide is conditionally authorized nether nan waste and acquisition sanction Hepcludex successful nan European Economic Area and nan United Kingdom.

Getting backmost to Eiger and its shape 3 data, it issued its promised information successful nan early hours of 12/08/2022. The merchandise was headlined "Eiger Announces Both Lonafarnib-based Treatments successful Pivotal Phase 3 D-LIVR Trial successful Hepatitis Delta Virus (HDV) Achieved Statistical Significance Against Placebo successful Composite Primary Endpoint."

The marketplace reacted violently arsenic shown below:

Data by YCharts

In a news point released conscionable a fewer hours pursuing Eiger's information release, Seeking Alpha bruited nan market's verdict pinch nan headline:

Eiger plunges 70% aft late-stage information for chronic hepatitis candidate

The article that followed focused connected information concerns. It noted nan study included 2 arms, lonafarnib successful operation with:

1. protease inhibitor ritonavir unsocial (oral therapy) and
2. interferon peginterferon alfa (combination therapy).

In summation to nan 2 study arms location were 2 comparator arms, a placebo limb and an limb that conscionable received peginterferon alfa. The news study highlighted:

... 8% and 14% of patients successful oral and operation therapy arms reported treatment-emergent terrible adverse events, compared to 10% and 4% successful nan peginterferon alfa and placebo groups, respectively.

Notably, location were 2 deaths successful nan study: One successful nan lonafarnib/ritonavir arm, which was unrelated to nan study drug, and different successful nan peginterferon alfa group.

As is communal erstwhile a institution issues important data, Eiger besides released an explanatory webcast, called "Phase 3 D-LIVR Study Results/December 08, 2022". The webcast provides a ~56 infinitesimal presentation, ~half reporting results pinch a 27 descent platform (the "Deck"), nan equilibrium responding to questions.

The Deck includes nan pursuing descent pinch nan underlying information information that was truthful troublesome:

ir.eigerbio.com

It will beryllium absorbing to spot really nan FDA reacts to Eiger's planned submission. The respective arms make nan information difficult to interpret. In nan webcast chat of descent 16, guidance characterizes nan therapy arsenic good tolerated. The marketplace seems to disagree; nan FDA will beryllium nan deciding referee.

Management upheaval coinciding pinch information merchandise invites speculation.

In summation to roiling its stock, Eiger's information merchandise seems to person confounded nan underlying guidance building astatine nan company. The release, which CEO Cory had anticipated during nan Call pinch specified optimism, preceded his abrupt resignation conscionable a scant fewer days later connected 12/15/2023.

As acold arsenic unit investors knew location were nary preliminaries. One time nan rumor was nan proceedings results axenic and simple, past nan adjacent came a merchandise headlined

President and CEO David A. Cory resigns from nan institution effective immediately

The institution appointed an Eiger seasoned and knowledgeable pharma executive arsenic interim CEO and began its hunt for a caller CEO. With nan ink hardly barren connected nan CEO's resignation, connected 01/03/2023 reports of CFO Ryali's impending resignation deed nan wire.

The Ryali move had amended optics than Cory's. Ryali gave two+ weeks' announcement and moved correct successful arsenic CFO of Codexis (CDXS). The timing was unfortunate for Ryali to person near Eiger successful nan mediate of its proceedings tribulations. It looks to maine arsenic much apt conscionable a profession move, than a CFO trying to flight difficult issues.

Eiger itself seems to return nan position that nan little said nan better. It issued an 8-K announcing nan resignation, but nary property merchandise announcing either nan resignation aliases nan assignment of a caller CFO. Its website doesn't database anyone successful nan CFO role. In consequence to a hunt for nan connection "financial", it returned a 12/2018 release announcing Ryali's assignment arsenic CFO.

The Presentation descent 2 included nan pursuing arsenic nan last slug constituent connected caller developments:

• CFO departure - Voluntary, amicable departure; soft modulation pinch continuity successful finance activity - Michelle Maynard, Sr VP Finance, is Acting Principal Accounting Officer

New England Journal Of Medicine article gave Eiger's banal an upward jolt.

On 02/09/2023 nan New England Journal Of Medicine published an article titled, "Early Treatment pinch Pegylated Interferon Lambda for Covid-19". nan article closed pinch nan pursuing conclusion:

Among predominantly vaccinated outpatients pinch Covid-19, nan incidence of hospitalization aliases an emergency section sojourn (observation for >6 hours) was importantly little among those who received a azygous dose of pegylated interferon lambda than among those who received placebo.

Eiger's banal reacted to nan article pinch a speedy upward tally to a precocious of $2.98 aft opening astatine $2.14. It closed nan time astatine $2.52. It has since drifted down closing connected 02/16/2023 astatine $2.20.

The publication included a bully affirmation of pegylated interferon lambda's antiviral effect, beyond that it whitethorn person small effect connected Eiger's COVID-19 strategy arsenic group retired successful its latest 10-Q (p. 23) of evaluating:

... adjacent steps for this programme successful nan U.S., arsenic good arsenic ex-U.S. emergency usage authorization pathways, and strategical options for nan continued improvement of peginterferon lambda for COVID-19 and different respiratory viral infections.

Eiger's 11/03/2022 Q3, reports supply nan latest disposable financial information.

Until its adjacent net study expected connected 03/10/2023, shareholders will person to trust connected reports from Q3, 2022 prepared by nan now absent Cory/Ryali. New CEO Appian will get to trial his guidance skills successful overseeing Eiger's 2022 twelvemonth extremity reports pinch Acting Principal Accounting Officer Maynard alternatively than an knowledgeable CFO astatine his side.

As for its Q3, 2022 net release, Eiger reported what it characterized arsenic a beardown rate position of $121.0 cardinal successful cash, rate equivalents, and full investments. Its mixed R&D positive SG&A expenses totaled $29.2 cardinal of which $4 cardinal were non cash.

It generated $4 cardinal successful revenues from waste of its first approved therapy Zokinvy arsenic described successful its latest 10-Q (p. 9). According to Eiger's Q4, 2021 net call it has identified ~20 patients successful nan US it is targeting for this therapy; truthful moreover astatine respective 100 1000 dollars for its yearly cost its gross imaginable is limited.

According to a caller article analysts person trim their yearly Zokinvy target for 2023 from $26 cardinal to 20 million. Eiger offers nary guidance arsenic a helping manus connected either revenues aliases expenses. Its Q3, 2022 10-Q (p. 4) reported aggregate quarterly nett nonaccomplishment of ~$27 million. Based connected its Q3, 2022 report, until it tin get a caller root of revenue, it will make yearly nett losses ~north of $100 cardinal .

Conclusion

Eiger is having a reliable go. Its shareholders are paying a steep price. I person rated it arsenic a hold. However I americium looking guardant to its expertise to correct nan ship. While its guidance shakeup was unfortunate, I expect it will soon beryllium forgotten.

I person not focused connected its pipeline but it has precocious shape therapies (Presentation descent 3) that it is developing. With its existent <$100 cardinal marketplace cap, an statement tin surely beryllium made that it is approaching bargain territory,

A bull thesis for Eiger would stress its:

1. solid liquidity,
2. potential adjacent word NDA for HDV,
3. late shape pipeline.

It is correct adjacent a tipping point, arsenic illustrated by its quicksilver guidance to nan diary article. Eiger is simply a trader's delight. As an investor, I americium taking a blimpish position and holding backmost for nan clip being.

Editor's Note: This article covers 1 aliases much microcap stocks. Please beryllium alert of nan risks associated pinch these stocks.

Writing nether nan pseudonym "out of ignorance", I very overmuch respect investing arsenic a learning process. Investing failures are tuition paid. Investing successes participate nan trove of lessons learned. In my Seeking Alpha articles I stock my acquisition from decades of investing and from ~5 years of focused investigation connected a assortment of stocks, successful caller years pinch a superior accent connected healthcare stocks. I greatly admit those who return nan clip to stock their reactions to articles, peculiarly those who stock applicable anecdotes and experiences.