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Time to add more to my portfolio. Never thought we would see PPS this low again. Cheers all….
Thanks Vin for your comments. I have faith and strongly believe both companies (ENTA, RVNC) by the end of the calendar year will be more appropriately valued as events unfold. My last purchase of ENTA at $24 I thought was an excellent deal. Clearly I could have waited a little longer.
Apropos IMGN, fun to watch it continue its climb north. Congrats sir!!
ENTA: Excellent point I completely overlooked admittedly. Thank you for also highlighting the investment (% shares)these Executives already have.
As to RVNC Executives, perhaps they too may be limited in what they may be able to do especially given near term PDUFA date for sBLA in CD.
Apropos RVNC and ENTA, it sure would be reasonable and reassuring to see the respective Executives step up and do some serious buying of stock at these grossly undervalued prices. Hard to fathom actually. I’m long term hold on both, not concerned, just bewildered.
Thanks Dew for sharing. Clearly the data from 235 was impressive enough for other companies to comment and acknowledge. I hope that this helps step up the pace of partnering. I do believe “timing” of a partnership deal is critical in that IF COVID variant(s) currently spreading in China along with other viruses like RSV start to surge later this year, ENTA will be in led with a potential treatment (of course down the road) especially for the immune compromised. Thx again!!
Congratulations Roy. Very impressive. Between DE and CAT, clearly points to great opportunities when patient and prudent about research.
LOL!!! That’s an understatement.
“extraordinary calm”…..calm before the storm perhaps? When it’s too quiet for too long, I become suspicious. Albeit that’s me…..
Thank you for outlining the EV presently. Added to my position this morning 10,000 at $24.00. Fascinating story and interesting to watch the developments the balance of 2023/2024.
“Special shareholders meeting: The company will hold a special shareholders meeting May 19 to vote on an amendment to the company’s articles of incorporation that increases the number of ordinary shares authorized for issuance from 150,000,000 to 225,000,000. The purposes of this increase - which include providing the company with the flexibility to issue ordinary shares in connection with a commercial or strategic partnership, to pay down debt or to fund operations - are outlined in the company’s proxy statement. Following the increase, if approved, all ordinary shares issuable from the company’s authorized share capital would have the same voting rights and rights to any dividends or other distributions by the company as the ordinary shares currently issuable from its share capital.”
As expected…..
I don’t think the roller coaster ride is even close to being done!! LOL After hours will give us some idea for sure what we might expect the balance of the week will be like.
Congratulations to us all for being “patient”, especially on days it looked rather bleak. May you all have a wonderful weekend. Cheers
Couldn’t be happier!!! Woot!
Hopefully after the first patient is treated with a positive outcome, Gamida will issue a PR highlighting their success. At that time we might finally appreciate a raise in the share price, albeit in a limited fashion. Due to the probability the company will need to raise more working capital, I suspect this overhang will limit upward movement in the PPS. Just my opinion & perspective.
If this was the case, wouldn’t selling the company outright sooner than later, be the most prudent step to take for all? Sorry to butt in. Just thinking along the lines of Joe.
Revance Reports First Quarter 2023 Financial Results, Provides Corporate Update
May 09 2023 - 04:05PM
Business Wire
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- Q1 total revenue of $49.3 million, a YoY increase of 95.3%.
- Q1 RHA® Collection revenue of $30.3 million, a YOY increase of 45.3%.
- Q1 DAXXIFY® revenue of $15.4 million, driven by PrevU and March launch.
- FDA approves Ajinomoto Biopharma Services, Revance’s contract manufacturer for DAXXIFY®.
- Fosun Pharma’s BLA submission for DaxibotulinumtoxinA for Injection for glabellar lines accepted for review by China’s National Medical Products Administration (NMPA).
- Conference call and webcast today at 4:30 p.m. ET.
Revance Therapeutics, Inc. (RVNC), today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.
Financial Highlights
Total revenue for the first quarter ended March 31, 2023 was $49.3 million compared to $25.3 million for the same period last year, representing an increase of 95.3% primarily due to the growth of the RHA® Collection of dermal fillers and revenue from DAXXIFY®. Revenue for the first quarter included $30.3 million of RHA® Collection revenue, $15.4 million of DAXXIFY® revenue, $3.6 million of service revenue and $0.1 million of collaboration revenue.
Selling, general and administrative (SG&A) expenses for the first quarter ended March 31, 2023 were $66.0 million compared to $45.1 million for the same period in 2022, presented in accordance with U.S. generally accepted accounting principles (“GAAP”). The increase was primarily due to higher sales and marketing expenses related to DAXXIFY® and the RHA® Collection. Excluding depreciation, amortization and stock-based compensation, non-GAAP SG&A expenses were $53.6 million for the first quarter ended March 31, 2023, compared to $35.8 million for the same period in 2022.
Research and development (R&D) expenses for the first quarter ended March 31, 2023 were $23.2 million compared to $30.7 million for the same period in 2022. The decrease was primarily due to lower clinical trial and regulatory activity. Excluding depreciation, amortization and stock-based compensation, non-GAAP R&D expenses were $17.9 million for the first quarter ended March 31, 2023, compared to $24.1 million for the same period in 2022.
Total operating expenses for the first quarter ended March 31, 2023 were $107.4 million compared to $87.5 million for the same period in 2022. Excluding costs of revenue, depreciation, amortization and stock-based compensation, non-GAAP operating expenses for the first quarter ended March 31, 2023 were $71.5 million, compared to $59.9 million for the same period in 2022.
Net loss for the first quarter ended March 31, 2023 was $59.8 million compared to a net loss of $64.3 million for the same period in 2022.
Cash, cash equivalents and short-term investments as of March 31, 2023 were $273.9 million.
“We are very pleased to see our momentum continue into 2023 with outstanding Q1 results driven by DAXXIFY’s market introduction and the continued growth of the RHA® Collection,” said Mark J. Foley, Chief Executive Officer. “Importantly, DAXXIFY’s launch is off to a great start, and we remain highly encouraged by the strong enthusiasm for the product’s differentiated performance profile and the positive feedback we’ve received from both injectors and consumers. Further, with our contract manufacturer, Ajinonomoto Biopharma Services, now approved by the FDA, we believe we are well positioned to support the expected demand for DAXXIFY®, in both aesthetics and therapeutics, as we continue to scale our business.”
First Quarter Highlights and Subsequent Updates
RHA® Collection revenue increased 45.3% year-over-year to $30.3 million in the first quarter 2023.
DAXXIFY® launch off to a great start, generating $15.4 million in revenue for the first quarter 2023. Following the conclusion of the PrevU early experience program in March, Revance initiated the market introduction of DAXXIFY® with an initial focus on its existing practice partners.
Aesthetics sales force expansion completed. At the end of the first quarter, Revance hired ~50 additional sales representatives, bringing its total sales force to over 150 representatives.
Accounts across Revance’s aesthetics portfolio totaled over 5,500 at the end of first quarter 2023.
In March, the FDA approved the prior-approval supplement (PAS) for Ajinomoto Biopharma Services (Aji), Revance’s fill-finish contract manufacturer. With approval, Aji will support the commercial growth of DAXXIFY® and all inventory produced at Aji, prior to approval, has been released for commercial use.
Gross payment volume (GPV) for the OPUL® Relational Commerce platform totaled $180.4 million for the first quarter 2023 and $690 million for the trailing-twelve months ended March 31, 2023.
In April, Fosun Pharma’s biologics license application (BLA) submission for DaxibotulinumtoxinA for Injection for glabellar lines was accepted for review by China’s NMPA. Revance entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (Fosun Pharma Industrial), a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., in 2018, whereby Revance granted Fosun Pharma Industrial the exclusive rights to develop and commercialize (excluding manufacturing) DaxibotulinumtoxinA for Injection in mainland China, Hong Kong and Macau.
2023 Financial Outlook
Revance expects 2023 GAAP operating expenses to be $460 million to $480 million and non-GAAP operating expenses, which exclude costs of revenue, depreciation and amortization and stock-based compensation to be $320 million to $340 million. Revance expects 2023 non-GAAP research and development expense to be $80 million to $90 million. The company’s non-GAAP operating expense guidance for 2023 primarily reflects increased investments in its aesthetics commercial infrastructure, including sales team expansion, DAXXIFY® and RHA® Collection commercial investments, and biosimilar partnership investments.
With current cash, cash equivalents and short-term investments, an additional $100 million of notes available for issuance through Athyrium Capital, and anticipated revenues and expenditures, management projects that the company’s U.S. aesthetics portfolio (DAXXIFY®, RHA® Collection, OPUL®) will be funded to cash flow breakeven.
It’s awesome to see IMGN and all the shareholders hang tight to the run up past $12.50 regardless of what all the silly negative shorts attempt to accomplish. Happy Cinco de Mayo to everyone and have a great weekend.
IMGN sells 29.9M* shares @$12.50
Very impressive!!
https://finance.yahoo.com/news/immunogen-announces-pricing-upsized-public-234500092.html
Congratulations Vin apropos IMGN. Incredible jump this morning sir.
“Another capital raise at some point over the next year cannot be counted as well. That said, given Omisirge's potential peak sales compared to the stock's current market cap, the equity deserves a small 'watch item' holding until data on the initial launch is seen in the quarters ahead.”
I suspect this last paragraph which is a fair assessment in my opinion will keep the PPS (Market Cap) low for sometime to come until we investors hear from the company that the soft launch is going well. Following through is critical for upward movement and to gain confidence and trust by the investor community. The additional capital raise “could” keep the PPS below $2 for some time to come. Thoughts? TIA
Thanks for sharing Roy. With M&A on the uptick so far in 2023, certainly will be fun to see what transpires with companies like ENTA and RVNC, both admittedly I’m overweight in. Do you and others here have any guesses on who would beg best to take out ENTA? Thank you in advance.
Congratulations, very impressive. That’s a lot of laps and time commitment in the pool. Best wishes for continued success.
Respectfully…..
Thank you for sharing this information Eric. I had heard at one point in time about this phenomenon, “subsidence”, albeit didn’t know the official name and the degree the East Coast is experiencing.
Makes total sense, the more you pull out of the ground (whether it be water, oil, etc), the more of a collapse/sinking that area could realize. Everything we humans touch has an impact on this planet. The more “civilized” a community, the more dramatic/negative the impacts are, in this case the slow collapse of the earths crust.
Never boring that’s for sure!!
“Very true, but I have been doing the opposite, slowly buying not just ENTA but several stocks including RVNC, ABBV and GILD”.
I like this approach myself. Added to my RVNC position today as well. I have to work 7 more years and have no qualms about adding to my core holdings on days where others decide to exit. Cheers.
Snagged 1,000 shares. Too cheap to pass on.
Enanta Pharmaceuticals Announces Sale of a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (Glecaprevir/Pibrentasvir) to OMERS Life Sciences for $200 Million
Non-Dilutive and Strengthens Balance Sheet
Competitive Process Results in the Sale of 54.5% of the MAVYRET®/MAVIRET® Royalty Interest, Subject to a 1.42x Cap
Sale Proceeds to Fund Continuing Clinical Development Across Virology Pipeline
April 25, 2023, 8:01 AM EDT
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced the sale to OMERS, one of Canada’s largest defined benefit pension plans, of 54.5% of Enanta’s future royalty payments from AbbVie Inc. on worldwide sales of MAVYRET®/MAVIRET®. The purchase price paid to Enanta was $200 million. OMERS right to receive royalty payments is based on net sales of the product beginning in July 2023 through June 2032, with total payments capped at 1.42 times the purchase price. Enanta retains 45.5% of all royalties until the cap is hit, at which point 100% of all further royalties revert to Enanta.
“We are pleased to partner with OMERS and its Life Sciences team to secure additional non-dilutive funding, which not only provides us with increased financial flexibility and retained economics, but also demonstrates the continued value of MAVYRET®/MAVIRET® and its significance for patients who continue to benefit from this therapy,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “As we execute on our programs, these funds enable us to continue to advance our robust pipeline of treatments for life-threatening viruses.”
“Enanta is a leader in small molecule drug discovery as evidenced by the successful development and commercialization of MAVYRET®/MAVIRET® in collaboration with AbbVie,” said Rob Missere, Managing Director & Head of OMERS Life Sciences. “We are pleased to invest in future sales of MAVYRET®/MAVIRET®, an important cure for chronic hepatitis C virus infection. This deal furthers our mandate to deliver an attractive source of long-term returns for our more than 560,000 members.”
MAVYRET®/MAVIRET® is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of chronic hepatitis C virus (HCV) infection. Glecaprevir was discovered by Enanta under a collaboration between AbbVie and Enanta to discover and develop protease inhibitor treatments for chronic HCV infection. MAVYRET®/MAVIRET® was launched globally beginning in 2017.
Interesting comment for sure!! Definitely nice to be on the upside and now all we have to do is be patient as progress plays out.
Wholeheartedly agree!!! It’s been quite the journey.
I have to admit sir, I too am surprised how well the stock is holding up. Right when I think I understand things, the market provides me a polite reminder on how little I know and can expect.
Certainly removes the overhang of concern about availability of working capital for operations. Thanks for the comments.
Gamida Cell Announces Launch of Public Offering of Securities
https://www.businesswire.com/news/home/20230418006253/en/Gamida-Cell-Announces-Launch-of-Public-Offering-of-Securities
Well that didn’t take long……
Thanks Midas. Curious what and where you think GMDA goes from here sir. I’m still having onto ALL of my shares and have barely an idea where things go from here.
Would the company, investors and blood cancer patients be better served by a much larger pharmaceutical company that has the appropriate resources to support the patient population?
Not sure if a BO is the best for investors at this moment. We half joked about the crazy rollercoaster ride scenario we were on!! Who would have imagined FDA approval early (before May 1) and so soon after GMDA managements fugly guidance they provided only weeks ago that precipitated the free fall in GMDA’s market capitalization.
I’d like to get off this ride at sometime albeit not before the game play’s it’s to a conclusion.
Anyone care to share their thoughts?
Thanks all.
A nice little surprise, earlier than we had hoped for. The next question is what price will the raise be at? Or just go for a complete buy out to the highest bidder assuming there is one.
With the disclosure by management there were no additional questions by the FDA, maybe to your point sentiment is more positive by the investment community?
Two weeks from today, May 1 we shall find out. I initially thought there would be a little run up to $2.00 prior to May 1. The most recent financial update from GMDA definitely hurt the PPS to squash my expectations. All of us in a wait and see mode for sure!!
I’m “uncertain” they will get approval on May 1. I agree, the science is very compelling. I’m concerned that the FDA will come back asking for more details. I’ve never suggested they won’t eventually get approval. I’ve invested a considerable amount of proceeds since I started following this company and opportunity.
With all the changes in Management this last year, it leaves me feeling less confident, simply stated. Make sense?
Thanks for the summary. I concur with all you shared and unfortunately think if they don’t get an FDA approval come May 1, our investments are gone and bankruptcy to follow. Given the challenges of the financial industry today, I do not see a path forward that make sense to me. Hope and a prayer are clearly NOT a good investment strategy. I just didn’t see this going they way it did. Shame on me.
Interesting and thanks for sharing Midas. At this point I’d be very happy at $5/share. Interesting times sir…..
I’m considering doing the same sir.
OMG that’s awful. I had no idea how severe the impact was on Scotland. Thanks for sharing.