IPO Preview: Calliditas Therapeutics Starts U.S. IPO Effort
Calliditas Therapeutics AB (CALT) has filed to raise $75 million in an IPO of its ADSs representing common shares, according to an F-1 registration statement.
The company is developing drug treatments for renal and hepatic disease conditions.
CALT has produced promising Phase 2 trial results for its lead candidate.
Stockholm, Sweden-based Calliditas was founded to focus on renal and hepatic diseases and is advancing a pipeline of treatments for IgA Nephropathy and primary biliary cholangitis [PBC].
Management is led by Renee Aguiar-Lucander, who has been with the firm since May 2017 and was previously Partner at Omega Fund Management, a life science venture capital firm.
Below is a brief overview video of Calliditas' approach:
Source: Biotech showcase
The firm's lead candidate, Nefecon for the treatment of IgAN, a serious autoimmune disease of the kidney, is currently in Phase 3 trials.
The end of Phase 2 trials have been received favorably by the FDA, which 'has indicated alignment on a pathway toward accelerated approval in the United States based on the evaluation of a surrogate endpoint rather than a clinical outcome endpoint. We have received similar feedback from the EMA on a conditional market access pathway in the European Union.'
Below is the current status of the company’s drug development pipeline:
Investors in the firm have invested at least $129.6 million and include Stiftelsen Industrifonden, Linc AB, Investinor AS, Fourth Swedish National Pension Fund, Gladiator, BVF Partners and Handelsbanken Fonder AB.
According to a 2020 market research report by Delve Insight, per a recent study, the global incidence of IgAN is at least 2.5 per 100,000 per year for adults.
And, one in four adults who have the disease eventually will have total kidney failure.
For children, one in every ten to twenty children will have total kidney failure as a result of contracting the disease.
Major competitive vendors that provide or are developing treatments include:
- Novartis (NVS)
- Merck KGaA (MRK)
Calliditas’s recent financial results are atypical of IPO stage biopharma firms in that they feature significant revenue in 2019.
Other aspects of the firm’s operational results are usual, such as the high R&D expenses associated with advancing its pipeline of drug programs.
Below are the company’s financial results for the past two and ¼ years (Audited IFRS for full years):
As of March 31, 2020, the company had $74 million in cash and $6.1 million in total liabilities. (Unaudited, interim)
Calliditas intends to raise $75 million in gross proceeds from an IPO of its ADSs representing common shares, although the final amount may be different.
The firm also intends to conduct a European private placement of an undetermined amount.
Calliditas is traded on the Swedish stock exchange under the symbol CALTX.
Management says it will use the net proceeds from the IPO to:
fund its ongoing Phase 3 clinical trial of Nefecon and, if the results from Part A of this Phase 3 clinical trial are positive;
file for regulatory approval in the United States and the European Union; to fund pre-commercial and, if approved, commercial activities for Nefecon for the treatment of IgAN;
and the remainder to fund the development of additional product candidates in indications for which Nefecon or its active ingredient may have therapeutic potential, including PBC and AIH, or for any product candidates that we in-license or acquire, and for working capital and other general corporate purposes.’
Management’s presentation of the company roadshow is not available.
Listed bookrunners of the IPO are Citigroup, Jefferies, Stifel and Carnegie.
Calliditas is seeking a typical IPO amount while the company is in Phase 3 trials for its lead candidate.
The firm’s lead candidate, Nefecon, expects to produce a topline data readout for its Phase 3 results in Q4 2020, only a few months away.
Additionally, if those results meet their endpoints, management expects to file an NDA and MAA in the first half of 2021.
The market opportunity is difficult to quantify in terms of dollars but is likely on the smaller size due to its low incidence, while the firm faces moderate competition.
Management has disclosed no commercial collaborations but the company has worldwide rights for its two programs, leaving maximum upside should the drugs be approved for marketing.
Citigroup is the lead left underwriter and IPOs led by the firm over the last 12-month period have generated an average return of negative (20.4%) since their IPO. This is a bottom-tier performance for all major underwriters during the period.
Depending on its proposed pricing and valuation, the CALT IPO looks promising, so I’ll provide a final opinion when we learn those details.
Expected IPO Pricing Date: To be announced.