Dynavax record hep B sales

 

• Net Product Sales: $79 million for Hep B in Q3 2024.

• Market Share: Hep B achieved 44% total U.S. market share in Q3 2024, up from 41% in Q3 2023.

• Gross Margin: Improved to 84% in Q3 2024 and 82% for the first nine months of 2024.

• Net Income: $18 million for Q3 2024.

• Cash and Equivalents: Approximately $764 million at the end of Q3 2024.

• Full Year Revenue Guidance: Narrowed to $265 to $270 million for Hep B net product revenue in 2024.

• R&D Expenses: $14 million for Q3 2024.

• SG&A Expenses: $43 million for Q3 2024, up from $38 million in Q3 2023.

• Share Repurchase Plan: $200 million authorized by the board.

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Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Dynavax Technologies Corp (NASDAQ:DVAX) reported record net product sales of $79 million for Hep B in the third quarter.

• The company achieved a 44% market share in the US for Hep B, up from 41% in the same period last year.

• Dynavax Technologies Corp (NASDAQ:DVAX) has authorized a $200 million share repurchase plan, indicating strong financial health.

• The company expects to achieve full-year profitability and positive net income for 2024.

• Dynavax Technologies Corp (NASDAQ:DVAX) is actively enrolling in a Phase 12 trial for its shingles vaccine program, with top-line data expected in the second half of 2025.

Negative Points

• The Phase 1 extension study for the TAP program did not meet the threshold for advancement, leading to its discontinuation.

• The company anticipates a typical year-end market contraction of approximately 15% due to fewer patient visits during the holiday season.

• Dynavax Technologies Corp (NASDAQ:DVAX) received a complete response letter from the FDA for the SBLA that adds a four-dose regimen for patients on hemodialysis.

• There is uncertainty regarding the timeline for FDA feedback on the proposed observational retrospective cohort study.

• The company faces challenges in developing a single-dose shingles vaccine candidate that meets non-inferiority margins compared to Shingrix.

Q & A Highlights

Q: With the updated 2030 market view, does the previous 2027 view of an $800 million total market still hold, or is it more linear growth to 2030? A: Ryan Spencer, CEO: We see this as an extension of our guidance to 2030, not a change to our 2027 expectations.

Q: Is the majority of growth between 2027 and 2030 coming from the retail channel, and what drives confidence in retail growth? A: Donn Casale, Chief Commercial Officer: Retail pharmacy is expected to drive growth due to infrastructure built post-pandemic and incentives for recommending adult vaccines. We see a shift from traditional hospital segments to retail.

Q: How do you expect gross margin to evolve over the next quarters, given the full-year guidance? A: Kelly MacDonald, CFO: While we expect continued progress in gross margin, there may be quarterly fluctuations due to accounting and timing of recognizing costs, particularly in our Germany facility.

Q: Does the $200 million share repurchase plan indicate a priority over external business development? A: Ryan Spencer, CEO: The share repurchase is part of a balanced capital allocation strategy. We remain focused on growth through external opportunities and believe there are still good opportunities available.

Q: Could the lower RSV vaccination rates impact Helia positively due to more capacity in the retail segment? A: Donn Casale, Chief Commercial Officer: While there's opportunity for a plus-one campaign for Hep B, we have factored this into our guidance for Q4 and early 2025.

Q: Are there any learnings from the T A vaccine program that could apply to other vaccine programs? A: Ryan Spencer, CEO: There's no negative read-through from one program to another. Each program is different, and we focus on building competitive products with high confidence in success.

Q: How do you view the possibility of a single-dose shingles vaccine candidate being non-inferior to Shingrix? A: Robert Janssen, Chief Medical Officer: A single dose is challenging due to reactogenicity. We will evaluate one dose, but success is uncertain. Higher reactogenicity than Shingrix is unlikely to be successful.

Q: Can you provide details on the plague vaccine program and expected feedback from the Department of Defense? A: Ryan Spencer, CEO: We are awaiting feedback from the Department of Defense on the contract and expect to hear back possibly this year or early next year.

https://finance.yahoo.com/news/dynavax-technologies-corp-dvax-q3-170203117.html

Rigel Q3 Up on Strong Sales

 

• Total Net Sales: $38.9 million, up 44% compared to Q3 2023.

• GAVRETO Net Product Sales: $7.1 million in its first full quarter.

• TAVALISSE Net Product Sales: $26.3 million, an 8% increase from Q3 2023.

• REZLIDHIA Net Product Sales: $5.5 million, a 107% increase from Q3 2023.

• Contract Revenues from Collaborations: $16.4 million, including $13 million from Kissei.

• Net Income: $12.4 million, compared to a net loss of $5.7 million in Q3 2023.

• Cash, Cash Equivalents, and Short-term Investments: $61.1 million at the end of the quarter.

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Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Rigel Pharmaceuticals Inc (NASDAQ:RIGL) reported a 44% increase in net sales for the third quarter of 2024 compared to the same period in 2023, driven by strong performance across its commercial portfolio.

• The addition of GAVRETO to Rigel's portfolio contributed $7.1 million in net product sales in its first full quarter, indicating successful integration and transition of patients and prescribers.

• Rigel expanded its international presence through a new agreement with Kissei to develop and commercialize REZLIDHIA in Japan, Korea, and Taiwan, which included a $10 million upfront payment.

• The company achieved positive net income for the third quarter and year-to-date, marking a significant financial milestone.

• Rigel is advancing its pipeline with promising developments, including the R289 dual IRAK 1 and 4 inhibitor in a Phase 1b study, and strategic collaborations with MD Anderson and CONNECT to explore new cancer treatments.

Negative Points

• Despite the positive sales growth, Rigel Pharmaceuticals Inc (NASDAQ:RIGL) faces challenges with some top centers not yet placing orders for GAVRETO, indicating potential logistical or market penetration issues.

• The company reported a gross-to-net adjustment of 36% for TAVALISSE, which may impact overall profitability.

• There are concerns about the safety profile of GAVRETO, with risks of severe and fatal infections due to off-target JAK1 and JAK2 inhibition, which could limit its uptake.

• Rigel's cost of product sales increased, driven by higher sales, royalties, and amortization of intangible assets, which could pressure margins.

• The competitive landscape for Rigel's products, such as the IRAK inhibitor space, remains challenging, with other companies exploring similar therapeutic areas.

Q & A Highlights

Q: Can you provide more color on TAVALISSE's balance between refills and new prescriptions? A: David Santos, Executive Vice President, Chief Commercial Officer: The majority of our business is carryover. Once patients start on TAVALISSE, they tend to stay on therapy, which contributes to our growth. New patient starts have also increased over the last couple of years, but the majority of growth is from existing patients continuing their treatment.

Q: Regarding GAVRETO, several top centers have not placed orders. Is this due to logistics? A: David Santos, Executive Vice President, Chief Commercial Officer: A handful of top centers haven't placed direct orders, which we are investigating. However, 45% of our business was through the distribution channel to direct accounts in Q3, and this improved to 50% in October, aligning more with our expectations.

Q: How should we think about the growth trajectory for GAVRETO, given its initial phase with Rigel? A: David Santos, Executive Vice President, Chief Commercial Officer: The majority of Q3 sales were true demand. We expect continued demand growth as more patients transition to our network. Dean Schorno, Chief Financial Officer, added that the majority of Q3 shipments were to patients and clinics, indicating strong demand.

Q: For R289 in lower risk MDS, what is the bar for success in Phase 1b to advance the program? A: Lisa Rojkjaer, Executive Vice President, Chief Medical Officer: The study is unique as it includes relapsed/refractory patients. While first-line treatments show about 40% response rates, our study's inclusion criteria differ. We are encouraged by the preliminary safety and efficacy data thus far.

Q: How might the new safety signal for GAVRETO affect its uptake, and does Retevmo have the same issue? A: Lisa Rojkjaer, Executive Vice President, Chief Medical Officer: The risk of infections is not new and is manageable by oncologists. The infections are primarily pneumonias, common in lung cancer patients. David Santos added that there have been no calls to their medical information line regarding this update, indicating no significant impact on GAVRETO's opportunity.

https://finance.yahoo.com/news/rigel-pharmaceuticals-inc-rigl-q3-072727180.html

Ardelyx Responds to District Court Decision Granting Motion to Dismiss

 Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today confirmed that Judge Beryl Howell from the U.S. District Court for Washington, D.C. has granted defendants’ motion to dismiss the lawsuit filed by Ardelyx, the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), permitting the Centers for Medicare and Medicaid Services (CMS) to proceed with its plan to include XPHOZAH® (tenapanor) and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS).

“We are disappointed and saddened by the Court’s decision to grant defendants’ motion to dismiss allowing CMS to bring PLTs into the Medicare ESRD PPS beginning on January 1, 2025. This will result in incredible harm to dialysis patients who, as a result of the bundled payment system, are unable to access the best care and medicine they require. Dialysis patients are among those who have historically experienced poorer health outcomes due to negative social determinants of health. And, while addressing health disparities has been a stated goal for CMS, this policy moves us in the opposite direction, resulting in severely restricted access to important medications,” said Mike Raab, president and chief executive officer of Ardelyx.

Raab continued, “Today’s decision reinforces our commitment to pursue all means for protecting patient access to XPHOZAH, including our choice not to apply for TDAPA in order to preserve the shared decision-making process between patients and healthcare providers who can best determine the best course of therapy to manage hyperphosphatemia. We also urge Congress to act swiftly on the overwhelming pleas from patients, physicians, faith leaders, labor unions and health equity advocates across the nation to pass the Kidney PATIENT Act.”

Ardelyx is currently reviewing the District Court’s decision and will consider all options related to the lawsuit.

https://www.globenewswire.com/news-release/2024/11/08/2977801/0/en/Ardelyx-Responds-to-District-Court-Decision-Granting-Motion-to-Dismiss.html

Revance Therapeutics stock sinks amid `going concern' disclosure

 Revance Therapeutics (RVNC) faces challenges as doubts over its ability to continue as a going concern arise

https://seekingalpha.com/news/4263827-revance-therapeutics-sinks-amid-going-concern-disclosure

Maravai Q3, pending acquisition

 Financial Highlights:

• Quarterly revenue of $65.2 million, Net loss of $(176.0) million (including a goodwill impairment of $154.2 million), and Adjusted EBITDA of $12.7 million; and
• Updated revenue guidance for the full year 2024 to be in the range of $255.0 million to $265.0 million.

Innovation and Awards:

• TriLink BioTechnologies (TriLink) enhanced our product offering with the introduction of custom sets of mRNA constructs, supporting our customers’ screening phase and allowing them to more quickly evaluate and prioritize their target;
• TriLink and Alphazyme collaborated to launch CleanScribe™ RNA Polymerase, providing researchers with a simple way to significantly reduce dsRNA in their IVT without compromising other important mRNA quality attributes;
• Commenced our first mRNA contract for a customer’s Phase II clinical trial in our Flanders 2 GMP manufacturing facility, demonstrating our ability to bring TriLink’s best-in-class mRNA manufacturing processes to our Phase II and Phase III mRNA service customers;
• Strengthened TriLink’s patent estate with the issuance of an additional U.S. patent for our CleanCap® IVT capping technology;
• Cygnus Technologies (Cygnus) and TriLink collaborated to launch AccuRes™ Host Cell DNA Quantification Kits. The all-in-one kit combines Cygnus’ proprietary extraction procedure with a probe-based master mix containing TriLink’s patented CleanAmp® dNTPs and a Hot Start Taq DNA Polymerase; and
• Chanfeng Zhao, Vice President, R&D Chemistry for TriLink was honored on the 2024 PharmaVoice 100 list in the category of Clinical Trial Pros.

Pending Acquisition:

• Entered into definitive agreement to acquire the DNA and RNA business of Officinae Bio, a privately held technology company with a proprietary digital platform designed with artificial intelligence and machine learning capabilities to support the biological design of therapeutics. The acquisition is subject to customary closing conditions, and is expected to close in early 2025. Once completed, the acquisition is expected to expand our ability to assist customers in developing innovative nucleic acid-based therapies.

Financial Guidance for 2024

Maravai’s financial guidance for the full year 2024 is based on expectations for its existing business and does not include the financial impact of potential new acquisitions, including the planned acquisition of the DNA and RNA business of Officinae Bio, or items that have not yet been identified or quantified. This guidance is subject to a number of risks, uncertainties and other factors, including those identified in “Forward-looking Statements” below.

Revenue expectations for 2024 are now expected to be in the range of $255.0 million to $265.0 million.

Adjusted EBITDA (non-GAAP) margins are now expected to be in the range of 16% to 18%.

Conference Call and Webcast

Maravai’s management will host a conference call today at 2:00 p.m. PT/ 5:00 p.m. ET to discuss its financial results for the third quarter of fiscal year 2024. Approximately 10 minutes before the call, dial (888) 596-4144 or (646) 968-2525 and reference Maravai LifeSciences, Conference ID 9502421. The call will also be available via live or archived webcast on the "Investors" section of the Maravai web site at https://investors.maravai.com/.

https://www.globenewswire.com/news-release/2024/11/07/2977089/0/en/Maravai-LifeSciences-Reports-Third-Quarter-2024-Financial-Results.html

Evolent Health falls on annual revenue, adjusted profit forecast cut

 ** Shares of healthcare services provider Evolent Health EVH.N fall 41.21% to $14.45

** Co cuts annual revenue forecast to be in the range of ~$2.55 billion to $2.58 billion, down from previous forecast of ~$2.56 billion to $2.60 billion

** Expects annual adjusted core profit to be between ~$160 million to $175 million vs about $230 million to $245 million previously expected

** Q3 rev. of $621.4 million misses est. of $627.15 million -LSEG

** Posts Q3 adj. core profit of $31.8 mln vs est. of $62.7 mln, impacted by elevated medical costs

** Stock down ~56% YTD

https://www.xm.com/research/markets/allNews/reuters/evolent-health-falls-on-annual-revenue-adjusted-profit-forecast-cut-53964577

Doximity Explodes as Doctors, Street Bet Big on Game-Changing Growth

 Doximity (NYSE:DOCS) is on fire. The stock exploded 37% Friday after the online medical platform smashed earnings expectations for fiscal Q2 2025. Revenue hit $136.8 millionup 20% year-over-yearblowing past the $127.1 million analysts had penciled in. Adjusted earnings of $0.30 per share also crushed forecasts of $0.26. But the real mic-drop moment? Over 600,000 doctors are now actively prescribing through Doximity's platform, setting a record and underscoring the company's game-changing role in healthcare. CEO Jeff Tangney nailed it: Doximity isn't just saving doctors time; it's rewriting the rules for how patient care gets delivered.

KeyBanc gave the stock a big thumbs-up, upgrading it to "Overweight" with a new $70 price target, citing "very healthy" earnings and long-term momentum. Wells Fargo joined the fan club, boosting its price target to $41 from $19. Both upgrades followed Doximity's revised full-year guidance, now forecasting revenue between $535 million and $540 million, with adjusted EBITDA expected to soar up to $279 million. The message? Doximity's growth story is just getting started.

Here's the kicker: Doximity's stock is up 52% this year, leaving the S&P 500's 25% gain in the dust. And it's not just hypethe company's financials are rock solid. Adjusted EBITDA margins jumped to 55.7%, and operating cash flow shot up 430% year-over-year to $68.3 million. With Q3 revenue projected at $152$153 million and adoption of its platform accelerating,

https://finance.yahoo.com/news/doximity-stock-explodes-37-doctors-163903622.html