Price Target Changed • Mar 14
Price target increased by 16% to US$22.50 Up from US$19.43, the current price target is an average from 6 analysts. New target price is 6.1% below last closing price of US$23.97. Stock is up 243% over the past year. The company is forecast to post a net loss per share of US$1.65 next year compared to a net loss per share of US$1.81 last year. Aankondiging • Feb 18
Provention Bio, Inc. Appoints Rita Jain to Audit Committee On January 3, 2023 the Board of Directors of the Provention Bio, Inc. appointed Rita Jain to the Board. On February 14, 2023, upon recommendation of the Nominating and Corporate Governance Committee of the Board, the Board appointed Dr. Jain to its Audit Committee, effective immediately. Following the appointment, the membership of the Audit Committee consists of: Avery Catlin (chair), Wayne Pisano and Dr. Jain. Recent Insider Transactions Derivative • Feb 16
Co-Founder & Chief Scientific Officer exercised options and sold US$577k worth of stock On the 13th of February, Francisco Leon exercised 76k options at a strike price of around US$2.50 and sold these shares for an average price of US$10.09 per share. This trade did not impact their existing holding. Since March 2022, Francisco has owned 2.57m shares directly. Company insiders have collectively sold US$3.1m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Feb 03
Provention Bio, Inc. Announces U.S. Commercial Launch of Tzield Provention Bio, Inc. announced the close of the $40 million second tranche under the previously announced term loan facility of up to $125 million with Hercules Capital, Inc. Under the terms of the term loan facility dated August 31, 2022, Hercules agreed to provide for up to $125 million of term loans in the aggregate, available to be funded in up to five tranches. The first tranche in an amount equal to $25 million was drawn at transaction close. Following the United States Food and Drug Administration (FDA) approval of TZIELD®, the Company has exercised the second tranche in an amount equal to $40 million. The third and fourth tranches will be available to the Company in an aggregate amount of up to $35 million, subject to satisfaction of certain conditions, including achievement of certain milestones. The availability of the fifth tranche of up to $25 million is subject to the approval of the lenders. On February 2nd, Provention Bio and Hercules Capital agreed to amend and restate the definition of Term Loan Interest Rate in the Loan and Security Agreement, dated August 31, 2022, to mean, for any day, a per annum rate of interest equal to the greater of either (i) the prime rate as reported in The Wall Street Journal plus 2.20% and (ii) 8.20%. This favorably compares to the previous definition of the greater of either (i) the prime rate as reported in The Wall Street Journal plus 2.70% and (ii) 8.20%. About TZIELD: TZIELD (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. TZIELD injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. TZIELD should be administered by intravenous infusion (over a minimum of 30 minutes) once daily for 14 days. Please see full prescribing information for the dosing schedule. If a patient needs help paying for TZIELD, Provention Bio'sPatient Assistance Program may be able to help. While co-pay amounts vary based on individual coverage, with the Provention Bio Copay Program, commercially or privately insured individuals enrolled in COMPASS may pay as little as $0 for TZIELD. If a patient qualifies, their COMPASS Navigator can help enroll them into the program so they may be able to lower their out-of-pocket costs. Recent Insider Transactions Derivative • Jan 22
Co-Founder exercised options and sold US$188k worth of stock On the 18th of January, Ashleigh Palmer exercised 24k options at a strike price of around US$2.50 and sold these shares for an average price of US$10.27 per share. This trade did not impact their existing holding. For the year to December 2017, Ashleigh's total compensation was 39% salary and 61% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2022, Ashleigh has owned 2.57m shares directly. Company insiders have collectively sold US$1.9m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Jan 06
Provention Bio, Inc. Appoints Rita Jain to Board of Directors Provention Bio, Inc. announced the appointment of Rita Jain, M.D., to the Company's Board of Directors. Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, Inc., AbbVie, Abbott Laboratories, and G.D. Searle and Co. prior to the latter's merger with Pharmacia & Upjohn and subsequent acquisition by Pfizer. Dr. Jain, a board-certified rheumatologist, currently serves as a member of the supervisory board of AM Pharma and previously served on the Board of Directors of ChemoCentryx, Inc. until its acquisition by Amgen. She previously served as Executive Vice President, Chief Medical Officer of ChemoCentryx, Inc., Chief Medical Officer of Immunovant, Inc. and prior to that, Senior Vice President and Chief Medical Officer of Akebia Therapeutics, Inc. Before joining Akebia, Dr. Jain served as Vice President of Men's and Women's Health and Metabolic Development at AbbVie, Inc., where she was responsible for leading the design and execution of multiple late-stage programs, including for Orilissa® and Oriahnn®, and in various leadership roles at Abbott Laboratories, including Divisional Vice President. She has also led programs across a diverse set of therapeutic areas, including inflammation, pain, immunology, and nephrology. Prior to her time at Abbott, she held management positions in the Arthritis, Inflammation and Pain Group at G.D. Searle, which was acquired by Pharmacia and, later, Pfizer. Earlier in her career, Dr. Jain served as a faculty member at North Shore University Hospital in New York. Dr. Jain received her M.D. from the State University of New York at Stony Brook School of Medicine and her B.S. in Biology from Long Island University/C.W. Post. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 8 analysts covering Provention Bio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$48.7m in 2025. Average annual earnings growth of 51% is required to achieve expected profit on schedule. Recent Insider Transactions Derivative • Dec 30
Co-Founder & Chief Scientific Officer exercised options and sold US$80k worth of stock On the 27th of December, Francisco Leon exercised 11k options at a strike price of around US$2.50 and sold these shares for an average price of US$10.00 per share. This trade did not impact their existing holding. Since March 2022, Francisco has owned 2.57m shares directly. Company insiders have collectively sold US$95k more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Nov 22
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$9.03m to US$10.0m. EPS estimate fell from -US$1.72 to -US$1.75 per share. Pharmaceuticals industry in the US expected to see average net income growth of 4.5% next year. Consensus price target up from US$15.52 to US$18.25. Share price fell 16% to US$7.77 over the past week. Price Target Changed • Nov 16
Price target increased to US$15.63 Up from US$14.50, the current price target is an average from 8 analysts. New target price is 72% above last closing price of US$9.06. Stock is up 33% over the past year. The company is forecast to post a net loss per share of US$1.72 next year compared to a net loss per share of US$1.81 last year. Major Estimate Revision • Nov 10
Consensus revenue estimates increase by 63% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$4.31m to US$7.02m. Forecast losses expected to reduce from -US$1.90 to -US$1.72 per share. Pharmaceuticals industry in the US expected to see average net income growth of 4.6% next year. Consensus price target up from US$14.50 to US$15.63. Share price rose 6.7% to US$7.12 over the past week. Price Target Changed • Nov 05
Price target increased to US$15.63 Up from US$14.50, the current price target is an average from 8 analysts. New target price is 112% above last closing price of US$7.38. Stock is up 7.9% over the past year. The company is forecast to post a net loss per share of US$1.76 next year compared to a net loss per share of US$1.81 last year. Major Estimate Revision • Aug 25
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$3.85m to US$4.54m. EPS estimate unchanged at -US$1.89. Pharmaceuticals industry in the US expected to see average net income decline 0.5% next year. Consensus price target of US$14.14 unchanged from last update. Share price fell 3.6% to US$4.81 over the past week. Seeking Alpha • Aug 12
Provention Bio: More Risk, More Dilution Ahead - Downgrading To A Sell Rating BLA was delayed again to October/November due to FDA's request around PK data.
Uncertainty around Teplizumab remains, and we are not a big fan of the FDA's recent request and delay in BLA.
The company's warrant structure looks messy; PRVB has a long history of punishing investors with stock dilution.
We downgrade the stock to sell from a hold rating.
BLA delayed again to October/November
The company provided additional color during the 2Q22 earnings call around information requests from the FDA; these are the key takeaways i) FDA information was requested from the FDA regarding incorporating ADA data in PK modeling of dosing regimen, ii) FDA's request resulted in the extended BLA decision date to Nov 17, iii) ADA does not impact the regimen for exposure or output of the model, and iv) there is no additional outstanding request from the agency at the moment.
The rationale for the delay?
FDA's rationale for the request during mid-June was to understand whether ADA levels would influence the recommended dosing adjustments set by the agency. As such, the company re-analyzed the data and found that the proposed dosing regimen remains unchanged by ADA levels and datapoints were consistent with the bioequivalency of legacy and commercial products. However, as the update was considered a major amendment, FDA indicated that they plan to discuss labeling and post-marketing requirements by Oct 17, 2022.
What next?
The key focus at this point is when investors will receive more clarity around the proc; during the Q2 earnings call, the company indicated that they would be able to provide additional regulatory updates during the Q3 earnings call planned around early Nov, based on their historical reporting timeline, as such, with the level of uncertainty, we remain on the sidelines.
Even though there were rumors about label discussion, which indicates a higher likelihood of approval of the agent, during the Q2 earnings call, the company emphasized that the proposed label discussion will only continue if there are no deficiencies identified during the review period (FDA will communicate to the company by Oct 17).
More messy warrants don't look good
...Today announced it has entered into a securities purchase agreement with institutional investors for the private placement of approximately $60 million of shares of its common stock and warrants to acquire 13,318,535 additional shares of its common stock (the "Warrants") (collectively, the "Securities"). The Warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $6.00 per share and will have a five-year term. Source: Provention Bio Announces $60 Million Private Placement
As we flagged in our previous report, the company raised additional capital to finance its operation. We are not a fan of messy warrants as they can dilute the share value. Major Estimate Revision • Aug 11
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$5.62m to US$3.85m. EPS estimate increased from -US$2.13 to -US$1.90 per share. Pharmaceuticals industry in the US expected to see average net income decline 3.9% next year. Consensus price target down from US$15.21 to US$14.14. Share price rose 23% to US$5.28 over the past week. Price Target Changed • Aug 08
Price target decreased to US$14.14 Down from US$15.21, the current price target is an average from 7 analysts. New target price is 203% above last closing price of US$4.67. Stock is down 24% over the past year. The company is forecast to post a net loss per share of US$1.91 next year compared to a net loss per share of US$1.81 last year. Price Target Changed • Aug 05
Price target decreased to US$14.64 Down from US$16.21, the current price target is an average from 6 analysts. New target price is 232% above last closing price of US$4.41. Stock is down 32% over the past year. The company is forecast to post a net loss per share of US$2.00 next year compared to a net loss per share of US$1.81 last year. Major Estimate Revision • Jul 12
Consensus revenue estimates increase by 11% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$5.06m to US$5.62m. Forecast losses expected to reduce from -US$2.16 to -US$2.13 per share. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target down from US$16.21 to US$15.21. Share price rose 8.5% to US$4.33 over the past week. Price Target Changed • Jul 11
Price target decreased to US$15.21 Down from US$16.50, the current price target is an average from 6 analysts. New target price is 251% above last closing price of US$4.33. Stock is down 35% over the past year. The company is forecast to post a net loss per share of US$2.16 next year compared to a net loss per share of US$1.81 last year. Major Estimate Revision • Jul 02
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$7.46m to US$5.06m. EPS estimate increased from -US$2.20 to -US$2.16 per share. Pharmaceuticals industry in the US expected to see average net income growth of 6.9% next year. Consensus price target of US$16.21 unchanged from last update. Share price fell 19% to US$3.43 over the past week. Major Estimate Revision • May 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$8.47m to US$7.46m. EPS estimate increased from -US$2.28 to -US$2.20 per share. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target of US$16.21 unchanged from last update. Share price fell 4.1% to US$3.96 over the past week. Major Estimate Revision • Mar 11
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$6.96m to US$9.60m. EPS estimate fell from -US$2.17 to -US$2.21 per share. Pharmaceuticals industry in the US expected to see average net income growth of 17% next year. Consensus price target of US$16.58 unchanged from last update. Share price rose 12% to US$6.58 over the past week. Major Estimate Revision • Mar 03
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$15.3m to US$6.96m. EPS estimate reaffirmed at -US$2.17 per share. Pharmaceuticals industry in the US expected to see average net income growth of 16% next year. Consensus price target broadly unchanged at US$16.58. Share price fell 3.1% to US$6.21 over the past week. Price Target Changed • Feb 25
Price target increased to US$16.75 Up from US$15.64, the current price target is an average from 6 analysts. New target price is 164% above last closing price of US$6.35. Stock is down 51% over the past year. The company is forecast to post a net loss per share of US$1.86 next year compared to a net loss per share of US$1.88 last year. Major Estimate Revision • Aug 06
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$11.3m to US$6.65m. EPS estimate increased from -US$2.24 to -US$2.13 per share. Pharmaceuticals industry in the US expected to see average net income growth of 13% next year. Consensus price target of US$16.36 unchanged from last update. Share price rose 7.2% to US$6.51 over the past week. Price Target Changed • Aug 06
Price target decreased to US$15.64 Down from US$17.36, the current price target is an average from 6 analysts. New target price is 140% above last closing price of US$6.51. Stock is down 47% over the past year. Price Target Changed • Apr 10
Price target decreased to US$21.14 Down from US$29.43, the current price target is an average from 7 analysts. New target price is 164% above last closing price of US$8.00. Stock is down 9.3% over the past year. Major Estimate Revision • Apr 06
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$29.6m to US$25.6m. EPS estimate increased from -US$2.31 to -US$2.17 per share. Pharmaceuticals industry in the US expected to see average net income growth of 16% next year. Consensus price target down from US$30.93 to US$29.43. Share price was steady at US$10.10 over the past week. Major Estimate Revision • Feb 28
Analysts lower EPS estimates to -US$2.68 The 2021 consensus revenue estimate was lowered from US$20.9m to US$20.2m. The company's losses are expected to worsen with analysts lowering their EPS forecasts from -US$2.09 to -US$2.68 for the same period. The Pharmaceuticals industry in the US is expected to see an average net income growth of 15% next year. The consensus price target increased from US$29.00 to US$29.43. Share price is down by 14% to US$12.72 over the past week. Is New 90 Day High Low • Feb 26
New 90-day low: US$12.83 The company is down 19% from its price of US$15.78 on 27 November 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$232 per share. Is New 90 Day High Low • Jan 13
New 90-day high: US$19.45 The company is up 49% from its price of US$13.03 on 14 October 2020. The American market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$257 per share. Is New 90 Day High Low • Nov 28
New 90-day high: US$15.78 The company is up 24% from its price of US$12.70 on 28 August 2020. The American market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$54.99 per share.