Research Notes

The first-quarter 2023 performance wasn't pretty, but it should mark the lowest quarterly revenue total of this decade.

The shifting timelines for clinical programs not named Vyjuvek / B-VEC is beginning to hamper the company's long-term ability to create value and live up to its true potential.

The precommercial drug developer has finally deprioritized wholly-owned gene therapy programs. Unfortunately, so have several other drug developers throughout the global landscape.

The gene therapy developer has an aesthetics subsidiary named Jeune Aesthetics. It recently dosed the first patient in the final cohort of an ongoing phase 1 clinical trial for KB301 in lateral canthal lines, or wrinkles on the upper cheek below the eyes, commonly called Crow's feet.

The business will hit an inflection point on revenue growth, mix, and quality this year. Coherus BioSciences expects to return to profitability in 2024.

The ReDiscover study evaluating RLY-2608 demonstrated industry-leading safety and tolerability, but initial efficacy data spooked investors. Wall Street is assuming the asset risks lagging the competitive landscape when combined with the chemotherapy drug fulvestrant.

The medical device company replenished its shelf registration with the SEC. Separately, AVITA Medical announced its third-generation automated ReCell device has earned FDA Breakthrough Device designation for acute wounds.

Solt DB Invest previously assigned a significantly higher probability of success (POS) to the pipeline at Relay Therapeutics than the industry average. We're increasing that metric in our modeling, which results in a higher Margin of Safety range

Initial data from two late-stage studies suggest SEL-212 can be commercially competitive with Krystexxa and its combination formulation. That increases the value of the royalty stream for Selecta Biosciences – or a financing partner

A quick update here before the company announces full-year 2022 operating results and gives the latest glimpse into its roadmap for 2023 and beyond.

The medical device company issued full-year 2023 commercial revenue guidance expecting 47% growth at the midpoint. It expects to end the year with a year-over-year growth exit rate of at least 50%.

The business grew Screening revenue 30% in 2022 from the year-ago period, but initial full-year 2023 revenue guidance expects the segment to grow "only" 18% at the midpoint. This is likely an underestimate.

The single-cell analysis pioneer ended a frustrating 2022 by launching a new instrument. Although the new Visium platform could re-accelerate growth in 2023, it might mask a bigger problem facing the business stemming from slowing consumables revenue growth.

Solt DB Invest initiates coverage of Centessa Pharmaceuticals, which is the 15th company to receive written coverage.

Solt DB Invest initiates coverage of Exscientia, which is the 14th company to receive written coverage.

Solt DB Invest initiates written coverage of Certara, which is the 13th company to receive coverage. Certara is a leader in biosimulation software and services for the global drug development industry.

Results from the multi-target stool DNA (MT-sDNA) portion of the BLUE-C study in colon cancer screening are expected in early 2023. A disappointing readout could crush the stock's rally, or lead to a short-term pop if the market gets carried away.

AVITA Medical remains one of the most obvious investment opportunities in the stock market. It's a #Dicerna level of conviction. The long-term guidance provided in February 2023 will force Wall Street to recalibrate significantly higher – closer to forecasts from Solt DB Invest.

A favorable study design suggests a positive outcome is likely for the upcoming phase 3 data readout for SEL-212 in early 2023. Here's what it needs to do to compete with Krystexxa.

Immune tolerance is quietly gaining traction in the global industry thanks to efforts from an emerging crop of private startups. The technology stack of Selecta Biosciences, anchored by ImmTOR-IL and Xork, is one of the best positioned.

Quick updates for Coherus BioSciences, Exact Sciences, Krystal Biotech, and Selecta Biosciences.

Our model increases significantly if Vyjuvek earns FDA approval in mid-February 2023 – from the current midpoint of $67.55 per share to a prospective midpoint of $108.07 per share ($124.28 per share excluding dilution).

Liquid biopsy screening tests for colorectal cancer (colon cancer) remain challenged in the competitive landscape, even with high adherence rates.

Oxford Nanopore is one of the few companies spreading a belief that the cost of biological experimentation should be dropping. It's one of the most important companies enabling the future of living tech.

China on Wednesday, December 7 ended many COVID-control measures following international business frustrations and rare protests. This development provides a window for American regulators to visit the Chinese manufacturing facility for toripalimab – the last remaining hurdle to earning marketing approval in the United States.

AVITA Medical remains one of the most obvious investment opportunities in the stock market. It's our first Asymmetric Opportunity. The long-term guidance provided in February 2023 will force Wall Street to recalibrate significantly higher – closer to forecasts from Solt DB Invest.

Solt DB Invest recommended closing positions in Twist Bioscience after a short report from Scorpion Capital published on Tuesday, November 15. Here are the reasons why we came to that conclusion and suspended coverage.

Solt DB Invest is recommending to close positions in Twist Bioscience. The quality control issues described in the short report, as well as surging operating expenses and loss of competitive positioning, can be corroborated with discussions I've had with customers.

The company remains on track to meet full-year 2022 revenue guidance of $138 million at the midpoint. Codexis is doing an excellent job growing product revenue excluding CDX-616 supply to Pfizer.

Full-year 2022 commercial revenue guidance has been raised from $30 million to $33.5 million at the midpoint, representing growth of 33% from the prior year. Commercial revenue excludes government revenue, but includes revenue sharing from Japan.

Management expects full-year 2023 revenue of at least $275 million. Wall Street analysts are expecting $463 million. However, the revenue floor is being misinterpreted, spooking markets, and unnecessary.

The soon-to-be commercial-scale gene therapy company has struggled to advance any asset aside from its lead drug candidate Vyjuvek. What's going on?

Management raised full-year 2022 revenue guidance and slashed operating expenses guidance. The new guidance ranges could still be too conservative.

The designation will ensure smooth communication between the company and regulators during the review process, which can reduce or eliminate delays. Importantly, it reduces review time from 10 months to just six months.

This article explores Solt DB Invest forecast and modeling in greater detail, including current expectations for revenue and profitability ramps.

Solt DB Invest initiates coverage of Exact Sciences, which is the 11th company in our coverage ecosystem. This article explains the competitive landscape in multi-cancer early detection (MCED) diagnostics.

Solt DB Invest initiates coverage of 10x Genomics, the 10th company in our coverage ecosystem. This article reviews the technology platform, upcoming product launch of Visium, and the valuation risk.

In a surprise announcement, James Corbett to replace Dr. Michael Perry as the Chief Executive Officer. Good riddance.

Solt DB Invest initiates coverage of Codexis with a careful review of enzyme engineering, the company's historical struggles, why we devalue the therapeutic pipeline, and what can be done to achieve success.

Our founder reduced the size of his positions in Certara and 10x Genomics to nearly double his position in AVITA Medical

(This is where the idea for Open Coverage was born.) More detailed data for RLY-4008 and a new collaboration with Foundation Medicine (Roche) to develop a companion diagnostic for the asset.

This article reviews the pivotal clinical trial results for the ReCell System in stable vitiligo and how it stacks up against the competitive landscape, namely Opzelura from Incyte Corporation.

This article explores an abstract for a poster and data presentation at the European Society of Medical Oncology (ESMO) Congress 2022.

A careful review of the opportunity in stable vitiligo, a comparison to the competitive landscape, and why Solt DB Invest doesn't expect material contributions any time soon.

Krystal Biotech announced on August 18 the FDA accepted its biologics license application (BLA) for Vyjuvek in dystrophic epidermolysis bullosa (DEB). Investors now have three more pieces of information regarding the regulatory pathway.

Solt DB Invest doesn't expect Udenyca OBI to launch, or more specifically, we expect Amgen to sue Coherus BioSciences and delay the launch.

Analysis of the ReCell System's performance in soft tissue repair, how it stacks up against the competitive landscape, and the likelihood of approval (hint: high).

The medical device company expects to announce data readouts from two clinical trials, one in soft tissue repair and one in stable vitiligo, in the second half of 2022. AVITA Medical reports second-quarter 2022 operating results after the market closes on Thursday, August 11.

Coherus BioSciences earned FDA approval for its first ophthalmology product, Cimerli (ranibizumab), a biosimilar to Lucentis.

I'm not confident the recent rally in the biotech sector can be trusted. I'm confident Twist Bioscience has significant valuation risk near current levels.

In relationships, it's important to keep the sex dirty and the fights clean. In DNA sequencing, it would be ideal to keep the samples dirty and the data clean. Oxford Nanopore and nanopore sequencing are the closest to this ideal technology.

Krystal Biotech will earn a priority review voucher (PRV) if Vyjuvek earns FDA approval, which seems very likely. The company can use it to accelerate regulatory review for a future asset, or sell it for over $100 million to another company to do the same.

This article explores how toripalimab (Tori) fits into the overall strategy and argues for investors to pay attention to a formidable growth engine.

Let's circle back around to the Relay Therapeutics pipeline update from June 27.

Some quick thoughts on an update from Relay Therapeutics about preliminary phase 1 clinical data for RLY-4008 (FGFR2).