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Evofem Biosciences Announces Financial Results for the First Quarter of 2024

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On May 15, 2024, Evofem Biosciences (OTCQB: EVFM) reported its financial results for Q1 2024. Key highlights include:

- Received $1M from Aditxt and an additional $2.5M investment by July 1, 2024.

- Strengthened intellectual property with the approval of a new patent for Phexxi.

- Partnered with Modern Remedies to boost Phexxi distribution in the Northeast.

- Renegotiated a 7.4% lower rebate for Phexxi with Medi-Cal, effective July 2024.

Financially, net sales were $3.6M, a 38% decrease from $5.8M in Q1 2023, attributed to cyclical softness and a cyberattack on Change Healthcare. Operating expenses decreased by 31% to $6.4M, leading to a reduced operating loss of $2.8M, a 21% improvement. Despite lower sales, the company expects 2024 to be its fourth consecutive year of net sales growth.

Positive
  • Received $1M from Aditxt and a commitment for an additional $2.5M by July 1, 2024.
  • Strengthened Phexxi intellectual property with a new patent approval.
  • Partnered with Modern Remedies to enhance Phexxi's distribution.
  • Renegotiated Phexxi rebate with Medi-Cal, resulting in a 7.4% reduction.
  • Operating expenses decreased by 31%, with selling and marketing costs down by 39% and G&A costs down by 22%.
  • Loss from operations improved by 21%, reducing to $2.8M.
Negative
  • Net sales decreased by 38% to $3.6M compared to Q1 2023.
  • The cyberattack on Change Healthcare negatively impacted sales and increased costs temporarily.
  • Evofem received no insurance claims for several weeks following the cyberattack, affecting Q1 results.
  • Despite cost reductions, the company still reported a loss from operations.

Insights

Evofem's recent financial results highlight a mix of challenges and strategic moves. The $3.6 million in net sales for Q1 2024, down 38% from the previous year, reflect both cyclical softness and unexpected disruptions such as the cyberattack on Change Healthcare. This emphasizes the importance of risk management and supply chain robustness in pharmaceutical operations.

On the positive side, the company's operating expenses saw a substantial decrement of 31%, leading to a narrowed loss from operations of $2.8 million, a marked improvement from the $3.6 million loss in Q1 2023. This indicates effective cost management amidst reduced revenues. However, the liquidity position remains weak with restricted cash at $0.7 million.

Investors should be cautious but note the potential for future growth driven by partnerships, such as the one with Modern Remedies and product innovation indicated by the new patent allowance. The upcoming investment from Aditxt and the anticipated closure of the merger in the latter half of 2024 could provide necessary financial stability and potential growth avenues.

The partnership with Modern Remedies and the renegotiated rebate with Medi-Cal are strategic moves to bolster market access and affordability of Phexxi. This indicates focused efforts on expanding market penetration and improving prescription volume in key regions. The lower rebates with Medi-Cal, effective from July 2024, could enhance margins and make Phexxi more accessible to a broader population, potentially driving long-term sales growth.

Additionally, the new patent allowance by the USPTO strengthens Evofem's intellectual property portfolio, providing a competitive edge and potentially deterring entry by generic alternatives. This solidifies Phexxi's market position and could lead to sustained revenue streams from the contraceptive market.

However, the decline in Q1 sales due to cyclic inventory patterns and external disruptions like the cyberattack underscores the volatility and dependence on external systems. Investors should keep an eye on how Evofem navigates these challenges and leverages its strategic partnerships and innovations moving forward.

From a clinical perspective, Phexxi’s role in supplementing oral contraceptives, especially with the increasing use of GLP-1 agonists like Mounjaro and Zepbound, presents a valuable clinical application. These medications are known to interfere with the efficacy of oral contraceptives, thus positioning Phexxi as an essential adjunctive therapy for women at risk of unintended pregnancies during critical periods of hormonal contraceptive efficacy reduction.

This application highlights an important niche market that Evofem is tapping into, potentially driving higher adoption rates among women on these therapies. The hormone-free, user-controlled aspect of Phexxi not only aligns with the growing demand for non-hormonal contraceptive options but also addresses specific needs unmet by traditional contraceptives.

Investors should consider the long-term potential of this growing market segment and how Evofem’s positioning could lead to sustained demand and revenue growth.

SAN DIEGO, May 15, 2024 /PRNewswire/ -- The company behind the hormone-free contraceptive Phexxi® (lactic acid, citric acid and potassium bitartrate), Evofem Biosciences, Inc. ("Evofem" or "the Company") (OTCQB: EVFM) today announced financial results for the first quarter of 2024. Highlights of and since the quarter include:

  • Received $1 million from Aditxt, Inc. (Nasdaq: ADTX) in May 2024 in consideration for reinstating and amending the Merger Agreement, as amended, between the companies. Aditxt agreed to invest an additional $2.5 million in Evofem by July 1, 2024. The companies are working to close the contemplated transaction in the second half of 2024.
      
  • Strengthened Phexxi intellectual property with the allowance of a new Composition of Matter Patent by the USPTO. Once issued, this will be the fifth U.S. patent covering Evofem's hormone-free contraceptive.
      
  • Launched a partnership with Modern Remedies, one of the top pharmacies dispensing Phexxi in the Northeast, effective May 2024.
      
  • Successfully renegotiated the rebate for Phexxi with Medi-Cal, the California state Medicaid program serving more than 15.4 million beneficiaries. Effective July 1, 2024, Evofem will pay a 7.4% lower rebate to Medi-Cal on Phexxi prescriptions dispensed to its beneficiaries.
      
  • Net sales were $3.6 million for the first quarter of 2024, reflecting anticipated cyclical softness following the wholesale acquisition cost (WAC) increase on January 1, 2024, and the impact of the cyberattack on Change Healthcare on February 19, 2024. 
      
  • Total operating expenses decreased 31% vs. the first quarter of 2023 to $6.4 million.
      
  • Narrowed loss from operations to $2.8 million, a 21% improvement compared to the first quarter of 2023.

"We expect 2024 will be our fourth consecutive year of net sales growth, driven in part by continued execution of our market access strategy with payer wins and successful rebate reductions," said Saundra Pelletier, Evofem's CEO. "We also expect lift from increasing use of Phexxi for supplemental contraception among women of reproductive age who take oral birth control pills in conjunction with GLP-1 agonists like Mounjaro and Zepbound. These drugs may make oral contraceptives less effective at certain points in the dosing schedule – specifically for four weeks after initiation and for another four weeks after each dose escalation. Adding a hormone-free, woman-controlled contraceptive like Phexxi is a logical choice for these patients for additional protection against unintended pregnancy during these times."

Financial Results

For the three months ended March 31, 2024, net sales were $3.6 million compared to $5.8 million in the prior year period. The 38% decrease reflects cyclical softness related to the timing of orders relative to WAC increases and the unfavorable impact of the cyberattack on Change Healthcare.

The typical cycle is that our customers A) place larger orders ahead of a price increase, B) sell from this inventory for several months after the price increase, and C) resume ordering the following quarter. Phexxi WAC increased on January 1, 2024, resulting in softer first quarter 2024 net sales (stage B). By contrast, following the October 2022 WAC increase and the near-absence of sales in the fourth quarter of 2022, net sales in the first quarter of 2023 were strong (stage C).

Following the cyberattack on Change Healthcare on February 19, 2024, retail pharmacies across the country experienced delays processing prescriptions and were unable to send orders through insurance plans, and there were delays in the processing of insurance claims, which lowered dispensed units of many prescription products, including Phexxi. Additionally, Change Healthcare was the sole adjudicator (processor) used by Evofem's co-pay card vendor and Evofem received no claims for several weeks following the cyberattack. In mid-March, our co-pay card vendor established an alternative adjudicator. Initially the cost to Evofem was significantly higher, which negatively impacted our first quarter results. Costs have dropped back down in the second quarter of 2024 to approximately 8% above pre-cyberattack levels.

Total operating expenses decreased 31% to $6.4 million, compared to $9.4 million in the prior year period. The improvement reflects a 39% decrease in selling and marketing costs and 22% decrease in general and administrative costs.

As a result, loss from operations improved to $2.8 million, compared with a loss from operations of $3.6 million for the three months ended March 31, 2023.

Liquidity

At March 31, 2024, we had $0.7 million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023.

Subsequent to the quarter close, in April 2024 Evofem made the required quarterly payment of $0.1 million to a U.S.-based, healthcare-focused institutional investor as required by the Fourth Amendment to the Securities Purchase and Security Agreement dated April 2020, as amended, under which this investor purchased $25 million of convertible senior secured promissory notes from Evofem in 2020.

In May 2024, Evofem received $1 million from Aditxt in consideration of reinstating and amending the Agreement and Plan of Merger, as amended on January 10, 2024, January 30, 2024, February 29, 2024, and May 2, 2024, by and between the companies. Under the Fourth Amendment to the Agreement and Plan of Merger, Aditxt agreed to invest an additional $2.5 million in Evofem by July 1, 2024. The companies are working to close the contemplated transaction in the second half of 2024.

About Evofem Biosciences
Evofem Biosciences, Inc., is developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com

Phexxi® is a registered trademark of Evofem Biosciences, Inc.

Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the Company's anticipated financial performance, the anticipated benefits of the contemplated Aditxt transaction, and timing thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024, its Quarterly Report on Form 10-Q for quarter ended March 31, 2024, filed with the SEC on May 15, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Contact

Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775

-- Financial Tables Follow -- 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited)

(In thousands)



As of


March 31, 2024


December 31, 2023

Cash and cash equivalents

$                    -


$                          -

Restricted cash

689


580

Trade accounts receivable, net

4,306


5,738

Total current liabilities

74,239


72,463

Total stockholders' deficit

(70,666)


(66,510)

Total liabilities, convertible and redeemable preferred
stock and stockholders' deficit

8,217


10,554

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 (Unaudited)

(In thousands, except share and per share data)






Three Months Ended March 31,




2024



2023


Product sales, net


$

3,603



$

5,809











Operating Expenses:









Cost of goods sold



684




1,376


Research and development



594




540


Selling and marketing



2,345




3,854


General and administrative



2,824




3,618


Total operating expenses



6,447




9,388


Loss from operations



(2,844)




(3,579)


Other income (expense):









Interest income



4




18


Other expense, net



(616)




(318)


Loss on issuance of financial instruments



(3,275)




(84)


Gain on debt extinguishment



1,120




-


Change in fair value of financial instruments



802




1,612


Total other income (expense), net



(1,965)




1,228


Loss before income tax



(4,809)




(2,351)


Income tax expense



-




(3)


Net loss



(4,809)




(2,354)


Convertible preferred stock deemed dividends



(47)




-


Net loss attributable to common stockholders


$

(4,856)



$

(2,354)


Net loss per share attributable to common stockholders









(basic and diluted):


$

(0.16)



$

(1.85)


Weighted-average shares used to compute net loss per share









attributable to common shareholders (basic and diluted):



31,194,393




1,271,524


 

 

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SOURCE Evofem Biosciences, Inc.

FAQ

What were Evofem Biosciences' net sales for Q1 2024?

Evofem Biosciences reported net sales of $3.6 million for the first quarter of 2024.

How did the cyberattack on Change Healthcare affect Evofem Biosciences?

The cyberattack led to delays in prescription processing and insurance claims, negatively impacting sales and increasing costs temporarily.

What investment did Evofem Biosciences receive from Aditxt in May 2024?

Evofem Biosciences received $1 million from Aditxt and a commitment for an additional $2.5 million by July 1, 2024.

What partnership did Evofem Biosciences announce effective May 2024?

Evofem partnered with Modern Remedies to enhance Phexxi distribution in the Northeast.

What change occurred regarding Phexxi's rebate with Medi-Cal?

Evofem renegotiated a 7.4% lower rebate for Phexxi with Medi-Cal, effective July 1, 2024.

EVOFEM BIOSCIENCE INC

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Biotechnology
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